## Protocol Section
### Identification Module
**NCT ID:** NCT06414746

**Acronym:** LOCUS

**Brief Title:** Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia

**Official Title:** A Multicenter Observational Retrospective-prospective Study of Prevalence, Clinical Characteristics of Hereditary Transthyretin Amyloidosis Polyneuropathy in Russian Patients Undergoing Surgery for CTS in Real Clinical Practice

#### Organization Study ID Info
**ID:** D8451R00001
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-16
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This is a multicenter observational study consisting of retrospective and prospective phases. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who underwent surgery for CTS to assess their probability of having ATTR PN.

**Detailed Description:** ATTR PN is a genotypically, phenotypically and geographically variable disease with a poor prognosis, albeit available disease-modifying drugs can change the disease trajectory. Thus country-specific epidemiologic data collection and identification of early stage PN, including previously misdiagnosed patients, is crucial to improve outcomes and quality of life. However, no observational studies on the epidemiology of ATTR PN in the whole Russian population, or in patients with CTS, have been performed.

Therefore, there is a need to conduct a large-scale observational study to determine the prevalence of ATTR PN in Russia, obtain information on patients' clinical characteristics, and determine their medical needs.

The approaches to diagnosis of ATTR PN in Russia over the past few years have been characterized by the use of heterogenous methods, partially explained by the lack of availability of molecular genetic testing, which is essential to diagnose the presence of pathogenic mutation in patients with hereditary ATTR PN. Thus, recent introduction of such tests into routine clinical practice may allow to assess reliable epidemiologic data including estimation of true ATTR PN prevalence among patients with CTS, which can often be the first manifestation of the disease. Earlier recognition, in turn, may lead to timely treatment initiation and change in the prognostic outlook of ATTR PN patients.

In order to assess the prevalence of ATTR PN in patients undergoing surgery for CTS in Russia this study will retrospectively include patients with the diagnosis of CTS undergoing surgery between the 1st January 2021 and the 1st September 2024. Suspicion of ATTR PN will be assessed in each case, and diagnostic tests (comprehensive neurological examination including nerve conduction study (NCS) combined with molecular genetic testing) to confirm or exclude the disease will be conducted prospectively in eligible patients. In addition to that, clinical features, concomitant manifestations, and diagnosed genotypes will be analyzed to examine characteristic ATTR PN patient profiles in the Russian Federation.

### Conditions Module

**Conditions:**

- Hereditary Transthyretin Amyloidosis

- Carpal Tunnel Syndrome

- Polyneuropathy

- Amyloidosis

**Keywords:**

- ATTR PN

- CTS

- PN

- carpal tunnel syndrome

- polyneuropathy

- amyloidosis

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 880

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** In order to achieve primary objective, the proportion of patients with confirmed diagnosis of ATTR PN (presence of TTR gene mutation according to the results of molecular genetic testing and clinical symptoms and/or signs of polyneuropathy) among those who underwent surgery for CTS will be calculated.

**Measure:** To define the prevalence of ATTR PN in patients undergoing surgery for CTS in routine clinical practice in the Russian Federation

**Time Frame:** Up to 12 months

#### Secondary Outcomes

**Measure:** To assess general demographic characteristics of patients with ATTR PN in Russia - Mean age (years) at the onset of CTS symptoms

**Time Frame:** up to 12 months

**Measure:** To assess general demographic characteristics of patients with ATTR PN in Russia: Mean age (years) at the onset of polyneuropathy symptoms

**Time Frame:** up to 12 months

**Measure:** to assess general demographic characteristics of patients with ATTR PN in Russia: Proportion of patients with late (>50 years) diagnosis of ATTR PN

**Time Frame:** up to 12 months

**Measure:** to assess general demographic characteristics of patients with ATTR PN in Russia: Mean age (years) at the time of CTS surgery

**Time Frame:** up to 12 months

**Description:** 1. Left hand;
2. Right hand;
3. Both hands;
4. First procedure;
5. Second and later procedures

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Number and proportion of patients with specific characteristic of index CTS download

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients with CTS recurrence after surgery

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients undergoing repeat surgery for CTS after the index operation

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients with PN progression after surgery

**Time Frame:** up to 12 months

**Description:** 1. 1 red flag;
2. 2 red flags;
3. 3 red flags;
4. 4-5 red flags;
5. 6-10 red flags;
6. \>10 red flags;

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Proportion of patients with different number of red flags:

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Mean age (years) at ATTR PN diagnosis

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of women and men

**Time Frame:** up to 12 months

**Description:** 1. Underweight (BMI \<18.5 kg/m2);
2. Normal weight (BMI ≥18.5 and \<25 kg/m2);
3. Overweight (BMI ≥25 and \<30 kg/m2);
4. Obesity (BMI ≥30 kg/m2)

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Mean body mass index (BMI) and proportion of patients with different BMI dimensions at the time of surgery and at Visit 1:

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Proportion of patients with a history of unexplained weight loss (≥5 kg) at any point since symptom onset

**Time Frame:** up to 12 months

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Mean and median time from CTS symptom onset (months) to ATTR PN diagnosis

**Time Frame:** up to 12 months

**Measure:** To assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Median number of physicians seen since symptom onset before the correct ATTR PN diagnosis

**Time Frame:** up to 12 months

**Measure:** To assess general demographic and clinical characteristics of patients with ATTR PN in Russia: Median number of hospitalizations for PN before the correct ATTR PN diagnosis

**Time Frame:** up to 12 months

**Description:** 1. CIDP;
2. Lumbar/sacral radiculopathy;
3. Lumbar canal stenosis;
4. Paraproteinaemic peripheral neuropathy;
5. Chronic progressive sensory/sensorimotor axonal idiopathic PN;
6. AL amyloidosis;
7. Fibromyalgia;
8. Other (specify)

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Number of patients with previously established incorrect diagnosis according to medical records, specifically with:

**Time Frame:** up to 12 months

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN: Proportion of patients with family history of neuropathic disease

**Time Frame:** up to 12 months

**Description:** 1. Neuropathic pain (allodynia, hyperalgesia);
2. Progressive sensory disturbances (loss of temperature, pain, other sensation);
3. Paresthesia, dysesthesia;
4. Progressive motor disturbances;
5. Walking difficulty, gait disorder;
6. Balance disorder

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN: Proportion of patients with specific peripheral neurological manifestations:

**Time Frame:** up to 12 months

**Description:** 1. 0;
2. I;
3. II;
4. IIIA;
5. IIIB;
6. IV;

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN: Proportion of patients with specific Polyneuropathy Disability (PND) classes:

**Time Frame:** up to 12 months

**Description:** 1. Upper-limb;
2. Lower-limb;
3. Both upper-limb and lower-limb

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Proportion of patients with specific distribution of polyneuropathy symptoms:

**Time Frame:** up to 12 months

**Description:** 1. Orthostatic hypotension;
2. Syncope;
3. Gastrointestinal motility disorders - i. Constipation; ii. Early satiety; iii. Diarrhea; iv. Nausea, vomiting;
4. Erectile dysfunction;
5. Neurogenic bladder;
6. Recurrent urinary infections;
7. Anhidrosis;

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with autonomic neurological manifestations, including specifically:

**Time Frame:** up to 12 months

**Description:** 1. Left ventricular hypertrophy;
2. Left bundle branch block;
3. Atrioventricular block;
4. Heart failure with preserved ejection fraction;
5. Elevated serum N-terminal-proB-type natriuretic peptide (NT-proBNP) concentration;
6. Cardiac valve stenosis;
7. Cardiac valve regurgitation;
8. Tachyarrhythmia;
9. Other (specify);
10. None;

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with concomitant cardiac manifestations, including specifically:

**Time Frame:** up to 12 months

**Description:** 1. Angiotensin converting enzyme inhibitor (ACEI) (specify);
2. Angiotensin receptor blocker (ARB) (specify);
3. Angiotensin receptor and neprilysin inhibitor (ARNI);
4. Sodium-glucose transporter type 2 inhibitor (SGLT2i) (specify);
5. Mineralocorticoid receptor antagonist (MRA) (specify);
6. Beta-blocker (specify);
7. Diuretic (specify);
8. Other cardiovascular (CV) medications (specify);
9. Other (specify);

**Measure:** Number of patients taking specific groups of cardiovascular medications at the time of CTS surgery and at the time of prospective visit:

**Time Frame:** up to 12 months

**Description:** 1. Vitreous body inclusions (opacification);
2. Glaucoma;
3. Abnormal conjunctival vessels;
4. Papillary abnormalities;
5. Dry eye;
6. Other (specify);

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with concomitant ophthalmologic manifestations, including specifically

**Time Frame:** up to 12 months

**Description:** 1. Spinal stenosis;
2. Osteoarthritis, including hip and knee arthroplasty;
3. Trigger finger;
4. Charcot's joints;
5. Biceps tendon rupture;
6. Rotator cuff injury;
7. Other (specify);

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - Number of patients with concomitant musculoskeletal manifestations, including specifically:

**Time Frame:** up to 12 months

**Measure:** Mean and median serum NT-proBNP (pg/ml) concentration

**Time Frame:** up to 12 months

**Measure:** Proportion of patients with laboratory confirmed paraproteinemia

**Time Frame:** up to 12 months

**Measure:** Mean and median urine albumin-creatinine ratio (UACR, mg/g of creatinine)

**Time Frame:** up to 12 months

**Description:** 1. Stage C1;
2. Stage C2;
3. Stage C3a;
4. Stage C3b;
5. Stage C4;
6. Stage C5;

**Measure:** Proportion of patients with diagnosed CKD, including specifically

**Time Frame:** up to 12 months

**Description:** 1. Elevated SCr level (based on the local laboratory reference range);
2. Decreased eGFR (\<60 ml/min/1.73m2);
3. Presence of albuminuria (≥30 mg/g creatinine (≥30 mg/g of creatinine or ≥30 mg/24h);
4. Presence of proteinuria (according to urinalysis results);
5. Ultrasound signs of amyloid nephropathy;

**Measure:** Number of patients with concomitant renal dysfunction, including specifically

**Time Frame:** up to 12 months

**Measure:** Number of patients with confirmed length-dependent peripheral sensory-motor neuropathy based on NCS results

**Time Frame:** up to 12 months

**Description:** 1. Left Medial;
2. Left Ulnar;
3. Left Sural;
4. Right Medial;
5. Right Ulnar;
6. Right Sural;

**Measure:** Mean and median measured peripheral sensory nerve conduction velocities

**Time Frame:** up to 12 months

**Measure:** Number of patients with reduced peripheral sensory nerve conduction velocity at ≥1 site

**Time Frame:** up to 12 months

**Description:** 1. Left Medial;
2. Left Ulnar;
3. Left Tibial;
4. Left Peroneal;
5. Right Medial;
6. Right Ulnar;
7. Right Tibial;
8. Right Peroneal;

**Measure:** Mean and median measured peripheral motor nerve conduction velocities

**Time Frame:** up to 12 months

**Measure:** Number of patients with reduced motor sensory nerve conduction velocity at ≥1 site

**Time Frame:** up to 12 months

**Description:** 1. Left Medial;
2. Left Ulnar;
3. Left Sural;
4. Right Medial;
5. Right Ulnar;
6. Right Sural

**Measure:** Mean and median measured sensory action potential (SAP) amplitudes

**Time Frame:** up to 12 months

**Measure:** Number of patients with reduced/absent SAP amplitude at ≥1 site

**Time Frame:** up to 12 months

**Description:** 1. Left Medial;
2. Left Ulnar;
3. Left Tibial;
4. Left Peroneal;
5. Right Medial;
6. Right Ulnar;
7. Right Tibial;
8. Right Peroneal

**Measure:** Mean and median measured distal compound muscle action potential (dCMAP) amplitudes

**Time Frame:** up to 12 months

**Description:** 1. Left Medial;
2. Left Ulnar;
3. Left Tibial;
4. Left Peroneal;
5. Right Medial;
6. Right Ulnar;
7. Right Tibial;
8. Right Peroneal

**Measure:** Mean and median measured proximal compound muscle action potential (pCMAP) amplitudes

**Time Frame:** up to 12 months

**Measure:** Number of patients with reduced/absent dCMAP amplitude at ≥1 site

**Time Frame:** up to 12 months

**Measure:** Number of patients with reduced/absent pCMAP amplitude at ≥1 site

**Time Frame:** up to 12 months

**Measure:** Proportion of patients with each score by each parameter of neurological examination

**Time Frame:** up to 12 months

**Description:** 1. Score 1 (no significant disability);
2. Score 2 (slight disability);
3. Score 3 (moderate disability);
4. Score 4 (moderately severe disability);
5. Score 5 (severe disability);

**Measure:** Number of patients in the specific categories of the modified Rankin scale

**Time Frame:** up to 12 months

**Description:** 1. 0 points;
2. 1 point;
3. 2 points;
4. 3 points;
5. 4 points;
6. 5 points

**Measure:** Proportion of patients with specific number of points according to Inflammatory Neuropathy Cause and Treatment (INCAT) upper extremity scale

**Time Frame:** up to 12 months

**Measure:** Median number of points according to INCAT upper extremity scale

**Time Frame:** up to 12 months

**Description:** 1. 0 points;
2. 1 point;
3. 2 points;
4. 3 points;
5. 4 points;
6. 5 points

**Measure:** Proportion of patients with specific number of points according to INCAT lower extremity scale

**Time Frame:** up to 12 months

**Measure:** Median number of points according to INCAT lower extremity scale

**Time Frame:** up to 12 months

**Measure:** Mean and median number of points according to combined clinical and electrophysiological score

**Time Frame:** up to 12 months

**Description:** 1. Val30Met;
2. Ile107Val;
3. Phe33Leu;
4. Ala81Val;
5. Ser23Asn;
6. Ala25Thr;
7. Val32Ala;
8. Thr40Asn;
9. Gly47Ala;
10. Glu54Gln;
11. Tyr69Phe;
12. Glu92Lys;
13. Thr119Met;
14. Other

**Measure:** To describe data on the results of genetic testing for ATTR in CTS patients undergoing surgery:Number and proportion of patients with specific TTR gene mutations

**Time Frame:** up to 12 months

**Description:** 1. CIDP;
2. Lumbar/sacral radiculopathy;
3. Lumbar canal stenosis;
4. Paraproteinaemic peripheral neuropathy;
5. Chronic progressive sensory/sensorimotor axonal idiopathic PN;
6. AL amyloidosis;
7. Fibromyalgia;
8. Other (specify);

**Measure:** to assess general demographic and clinical characteristics of patients with ATTR PN in Russia - Proportion of patients with previously established incorrect diagnosis according to medical records, specifically with:

**Time Frame:** up to 12 months

**Description:** manifestations, including specifically:

1. Orthostatic hypotension;
2. Syncope;
3. Gastrointestinal motility disorders - i. Constipation; ii. Early satiety; iii. Diarrhea; iv. Nausea, vomiting;
4. Erectile dysfunction;
5. Neurogenic bladder;
6. Recurrent urinary infections;
7. Anhidrosis;

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with autonomic neurological manifestations, including specifically:

**Time Frame:** up to 12 months

**Description:** 1. Left ventricular hypertrophy;
2. Left bundle branch block;
3. Atrioventricular block;
4. Heart failure with preserved ejection fraction;
5. Elevated serum N-terminal-proB-type natriuretic peptide (NT-proBNP) concentration;
6. Cardiac valve stenosis;
7. Cardiac valve regurgitation;
8. Tachyarrhythmia;
9. Other (specify);
10. None;

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with concomitant cardiac manifestations, including specifically:

**Time Frame:** up to 12 months

**Description:** 1. Angiotensin converting enzyme inhibitor (ACEI) (specify);
2. Angiotensin receptor blocker (ARB) (specify);
3. Angiotensin receptor and neprilysin inhibitor (ARNI);
4. Sodium-glucose transporter type 2 inhibitor (SGLT2i) (specify);
5. Mineralocorticoid receptor antagonist (MRA) (specify);
6. Beta-blocker (specify);
7. Diuretic (specify);
8. Other cardiovascular (CV) medications (specify);
9. Other (specify);

**Measure:** proportion of patients taking specific groups of cardiovascular medications at the time of CTS surgery and at the time of prospective visit:

**Time Frame:** up to 12 months

**Description:** 1. Vitreous body inclusions (opacification);
2. Glaucoma;
3. Abnormal conjunctival vessels;
4. Papillary abnormalities;
5. Dry eye;
6. Other (specify);

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with concomitant ophthalmologic manifestations, including specifically

**Time Frame:** up to 12 months

**Description:** 1. Spinal stenosis;
2. Osteoarthritis, including hip and knee arthroplasty;
3. Trigger finger;
4. Charcot's joints;
5. Biceps tendon rupture;
6. Rotator cuff injury;
7. Other (specify);

**Measure:** To describe data on the presence of cardiovascular, neurological and other comorbidities in Russian patients with ATTR PN - proportion of patients with concomitant musculoskeletal manifestations, including specifically:

**Time Frame:** up to 12 months

**Description:** 1. Elevated SCr level (based on the local laboratory reference range);
2. Decreased eGFR (\<60 ml/min/1.73m2);
3. Presence of albuminuria (≥30 mg/g creatinine (≥30 mg/g of creatinine or ≥30 mg/24h);
4. Presence of proteinuria (according to urinalysis results);
5. Ultrasound signs of amyloid nephropathy;

**Measure:** proportion of patients with concomitant renal dysfunction, including specifically

**Time Frame:** up to 12 months

**Measure:** proportion of patients with confirmed length-dependent peripheral sensory-motor neuropathy based on NCS results

**Time Frame:** up to 12 months

**Measure:** proportion of patients with reduced peripheral sensory nerve conduction velocity at ≥1 site

**Time Frame:** up to 12 months

**Measure:** proportion of patients with reduced motor sensory nerve conduction velocity at ≥1 site

**Time Frame:** up to 12 months

**Measure:** proportion of patients with reduced/absent SAP amplitude at ≥1 site

**Time Frame:** up to 12 months

**Measure:** proportion of patients with reduced/absent dCMAP amplitude at ≥1 site

**Time Frame:** up to 12 months

**Measure:** proportion of patients with reduced/absent pCMAP amplitude at ≥1 site

**Time Frame:** up to 12 months

**Description:** -a) Score 1 (no significant disability); b) Score 2 (slight disability); c) Score 3 (moderate disability); d) Score 4 (moderately severe disability); e) Score 5 (severe disability

**Measure:** proportion of patients in the specific categories of the modified Rankin scale

**Time Frame:** up to 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

for the retrospective phase are:

1. Patients with the established diagnosis of CTS undergoing surgical intervention between the 1st January 2021 and the 1st September 2024.
2. Age ≥ 18 years at the time of surgery.

   Additional inclusion criteria for the prospective phase are:
3. Provided written informed consent for the prospective phase of the study (including molecular genetic testing).
4. Bilateral CTS;
5. Presence of ≥1 of the following features (red flags):

   1. CIDP or polyneuropathy of unknown etiology in the family history;
   2. Spinal canal stenosis of the lumbar region;
   3. Autonomic dysfunction, defined by the presence of ≥1 of the following symptoms: i. gastrointestinal complaints (constipation, chronic diarrhea, or both); ii. erectile dysfunction; iii. orthostatic hypotension;
   4. Gait disorders;
   5. Sweating disorders, anhidrosis.
   6. Paresthesia and burning of the skin of the distal extremities
   7. Distal symmetrical paresis
   8. Hypotrophy and hypotension of limb muscles, areflexia
   9. Biceps tendon rupture
   10. Aortic valve stenosis
   11. Diagnosis of HFpEF
   12. Unexplained weight loss ≥5 kilos at any timepoint since the onset of symptoms of CTS;
   13. Left ventricular hypertrophy (based on electro- or echocardiographic criteria documented in the patient's medical record);
   14. Heart rhythm disorders;
   15. Renal abnormalities, defined by ≥1 of the following features - i. documented diagnosis of chronic kidney disease (CKD); ii. decreased estimated glomerular filtration rate (eGFR \<60 mL/min/1.73m2); iii. increased serum creatinine (SCr) above reference range of the local laboratory; iv. albuminuria (≥30 mg/g of creatinine or ≥30 mg/24h ); v. proteinuria (according to urinalysis results).
   16. Ophthalmology disorder defined by ≥1 of the following features - i. vitreous body inclusions (opacification); ii. Glaucoma; iii. pupillary disorders; iv. vitrectomy
6. Absence of previously established ATTR PN diagnosis (ICD-10 code Е85.1, "Neuropathic hereditary familial amyloidosis").

Exclusion Criteria:

for the retrospective phase are:

1. Participation in any interventional trial within the period since surgical intervention until the end of current study.

   Additional exclusion criteria for the prospective phase are:
2. Previously performed TTR genetic testing;
3. Verified B12 deficiency;
4. History of alcohol abuse according to the patient's medical record.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** This multicenter observational study will retrospectively include 4400 consecutive adult patients who underwent surgery for CTS in Russia, including approximately \~880 patients with CTS and high suspicion of having ATTR PN who will be enrolled in the prospective phase.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** information.center@astrazeneca.com

**Name:** AstraZeneca Clinical Study Information Center

**Phone:** 1-877-240-9479

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Research Site

**Status:** RECRUITING

**Location 2:**

**City:** Saint-Petersburg

**Country:** Russian Federation

**Facility:** Research Site

**Status:** RECRUITING

**Zip:** 194354

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000020423

- Term: Median Neuropathy

- ID: D000020422

- Term: Mononeuropathies

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009408

- Term: Nerve Compression Syndromes

- ID: D000012090

- Term: Cumulative Trauma Disorders

- ID: D000013180

- Term: Sprains and Strains

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000020271

- Term: Heredodegenerative Disorders, Nervous System

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000028226

- Term: Amyloidosis, Familial

- ID: D000008661

- Term: Metabolism, Inborn Errors

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M4021

- Name: Amyloidosis

- Relevance: HIGH

- As Found: Amyloidosis

- ID: M13999

- Name: Polyneuropathies

- Relevance: HIGH

- As Found: Polyneuropathy

- ID: M5603

- Name: Carpal Tunnel Syndrome

- Relevance: HIGH

- As Found: Carpal Tunnel Syndrome

- ID: M19981

- Name: Amyloid Neuropathies

- Relevance: HIGH

- As Found: Amyloidosis Polyneuropathy

- ID: M23330

- Name: Amyloid Neuropathies, Familial

- Relevance: HIGH

- As Found: Hereditary Transthyretin Amyloidosis

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22219

- Name: Median Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M22218

- Name: Mononeuropathies

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12352

- Name: Nerve Compression Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M5853

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18092

- Name: Hereditary Sensory and Motor Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M14930

- Name: Cumulative Trauma Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15974

- Name: Sprains and Strains

- Relevance: LOW

- As Found: Unknown

- ID: M22092

- Name: Heredodegenerative Disorders, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M23329

- Name: Amyloidosis, Familial

- Relevance: LOW

- As Found: Unknown

- ID: M11641

- Name: Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: T2264

- Name: Familial Transthyretin Amyloidosis

- Relevance: HIGH

- As Found: Transthyretin Amyloidosis

- ID: T340

- Name: Amyloid Neuropathy

- Relevance: HIGH

- As Found: Amyloidosis Polyneuropathy

- ID: T1081

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2761

- Name: Hereditary Motor and Sensory Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T2766

- Name: Hereditary Neuropathy With Liability to Pressure Palsies

- Relevance: LOW

- As Found: Unknown

- ID: T5067

- Name: Roussy Levy Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002349

- Term: Carpal Tunnel Syndrome

- ID: D000011115

- Term: Polyneuropathies

- ID: D000028227

- Term: Amyloid Neuropathies, Familial

- ID: D000017772

- Term: Amyloid Neuropathies

- ID: D000000686

- Term: Amyloidosis

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
