## Protocol Section
### Identification Module
**NCT ID:** NCT04743479

**Acronym:** ESPRIT-AI

**Brief Title:** Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)

**Official Title:** Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer

#### Organization Study ID Info
**ID:** ChanghaiH-PP07
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2030-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-31

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-12-01

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2021-02-08
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-03
**Study First Submit QC Date:** 2021-02-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhai Hospital

#### Responsible Party

**Investigator Affiliation:** Changhai Hospital

**Investigator Full Name:** Guo ShiWei

**Investigator Title:** Associated Professor at the Institute of Pancreatic Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Pancreatic cancer is one of the most fatal malignancies with a 5-year survival rate of only \~6%\[1\]. The reasons for this high mortality rate can be attributed to several factors, of which perhaps the most important is delayed diagnosis due to vague symptoms and consequently missed opportunities for surgical resection. Therefore, the ability to detect pancreatic cancer at an early, more curable stage is urgently needed.

Identifying risk factors and biomarkers of early pancreatic cancer could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease. Thus, the investigators propose this longitudinal study entitled, "Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)" in order to generate clinical data sets and bank serial blood specimens of high risk individuals.

**Detailed Description:** The study is being run by a team of dedicated physicians and researchers, led by Jin Gang, MD, Director of Department of general surgery of Shanghai Changhai Hospital. The trial will include individuals with new-onset diabetes (diagnosed within the past 3 year), familial pancreatic cancer, inherited syndromes associated with pancreatic cancer (including hereditary pancreatitis, familial atypical multiple mole and melanoma syndrome, hereditary nonpolyposis colon cancer, Peutz-Jeghers syndrome, hereditary breast and ovarian cancer syndromes, etc), pancreatic cystic neoplasm (including IPMN, MCN) as well as chronic pancreatitis. Participants will undergo annual laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS). If pancreatic cancer or a pre-cancerous lesion is identified, the individual will be referred for surgery. We will also be collecting a blood sample from all participants for DNA isolation. Clinical data and biological specimens contained in this study may be used for a wide variety of future related studies to the cause, diagnosis, outcome and treatment of pancreatic cancer.

### Conditions Module

**Conditions:**

- Pancreatic Cancer

- Diabetes

- Familial Pancreatic Cancer

- Pancreatic Cystic Neoplasm

- Chronic Pancreatitis

- Hereditary Pancreatitis

**Keywords:**

- Screening

- Early Diagnosis

- Artificial Intelligence

- Pancreatic Cancer

### Design Module

#### Bio Spec

**Description:** Patients in this study will have the option of donating blood for biobanking, approximately 10cc of plasma and 10cc of serum. Further, samples that are routinely collected for diagnostic purposes may be collected and banked at the time of their clinically routine procedure. If a patient consents to the use of extra material for research purposes, the biological samples will be banked and the blood, and/or pancreatic juice/cystic fluid, tissues, and saliva will be used for identification and characterization of potential biomarkers from de-identified samples.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 5000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** New Onset Diabetes must meet one of the following criteria:

1. Documented diabetes diagnosed within the past 3 years.
2. Definite new-onset diabetes based on recent fasting blood glucose (FBG) values ≥126 mg/dl (7.0 mmol/L) or Hemoglobin A1c (HbA1c) ≥ 6.5%. All glycemic parameters must be measured in an outpatient setting.

**Intervention Names:**

- Diagnostic Test: high-resolution MRI/CT examinations

**Label:** New Onset Diabetes

#### Arm Group 2

**Description:** Familial pancreatic cancer must meet one of the following criteria:

1. ≥ 2 blood relatives with pancreatic cancer (includes 1st-3rd degree relatives)
2. One 1st degree relative with PDAC diagnosed before age 60

**Intervention Names:**

- Diagnostic Test: high-resolution MRI/CT examinations

**Label:** Familial pancreatic cancer

#### Arm Group 3

**Description:** Family history includes with inherited syndromes associated with pancreatic cancer ( ≥ 2 blood relative, includes 1st-3rd degree relatives).

Inherited syndromes must meet one of the following criteria:

1. Hereditary pancreatitis
2. Familial atypical multiple mole and melanoma syndrome
3. Hereditary nonpolyposis colon cancer
4. Peutz-Jeghers syndrome
5. Hereditary breast and ovarian cancer syndromes

**Intervention Names:**

- Diagnostic Test: high-resolution MRI/CT examinations

**Label:** Inherited syndromes associated with pancreatic cancer

#### Arm Group 4

**Description:** Pancreatic Cystic Neoplasm, including intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN), which are defined by endoscopic ultrasound or serial imaging.

**Intervention Names:**

- Diagnostic Test: high-resolution MRI/CT examinations

**Label:** Pancreatic Cystic Neoplasm

#### Arm Group 5

**Description:** Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.

**Intervention Names:**

- Diagnostic Test: high-resolution MRI/CT examinations

**Label:** Chronic pancreatitis

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Chronic pancreatitis

- Familial pancreatic cancer

- Inherited syndromes associated with pancreatic cancer

- New Onset Diabetes

- Pancreatic Cystic Neoplasm

**Description:** Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

**Name:** high-resolution MRI/CT examinations

**Other Names:**

- questionnaire survey

- laboratory tests

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.

**Measure:** Incidence

**Time Frame:** 5 years

**Description:** Assesses the influence of risk factors on the incidence of pancreatic cancer or precursor lesions among high risk individuals.

**Measure:** Hazard ratio (HR)

**Time Frame:** 5 years

#### Secondary Outcomes

**Description:** Calculate survival time from point of diagnosis and treatment among the identified patients with pancreatic cancer.

**Measure:** Survival time

**Time Frame:** 5 years

**Description:** Assesses the influence of risk factors on survival time among the identified patients with pancreatic cancer.

**Measure:** HR

**Time Frame:** 5 years

**Description:** Determine diagnostic yield (sensitivity, specificity, positive/negative predictive value and accuracy) of AI-based surveillance program to predict early stage pancreatic cancer.

**Measure:** Diagnostic yield

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject is able and willing to provide informed consent and sign an informed consent form.
* Subject or authorized representative must be willing to complete a detailed questionnaire.
* Subject must meet one of the following criteria:

  1. New onset diabetes (diagnosed within the past 3 years)
  2. Familial pancreatic cancer
  3. Inherited syndromes associated with pancreatic cancer (including Hereditary pancreatitis, Familial atypical multiple mole and melanoma syndrome, Hereditary nonpolyposis colon cancer, Peutz-Jeghers syndrome, Hereditary breast and ovarian cancer syndromes, etc)
  4. Pancreatic cystic neoplasm (including IPMN, MCN)
  5. Chronic pancreatitis

Exclusion Criteria:

* Subject has been diagnosed with pancreatic cancer or other malignant tumors in the last 5 years;
* Subject has any medical condition that contraindicates high-resolution MRI or CT;
* Subject cannot be followed up or is participating in other clinical trials.

**Maximum Age:** 75 Years

**Minimum Age:** 50 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** High risk individuals of pancreatic cancer

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lilly_wang@126.com

**Name:** Beilei Wang, M.D.

**Phone:** 13774238083

**Role:** CONTACT

**Contact 2:**

**Email:** gestwa@163.com

**Name:** Shiwei Guo, M.D.

**Phone:** 18621500666

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** lilly_wang@126.com

- **Name:** Beilei Wang, M.D.

- **Phone:** 13774238083

- **Role:** CONTACT

***Contact 2:***

- **Name:** Gang Jin, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Bimeng Zhang, M.D.

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Shanghai Changhai Hospital

**Status:** RECRUITING

**Zip:** 200433

#### Overall Officials

**Official 1:**

**Affiliation:** Department of general surgery, Changhai Hospital

**Name:** Gang Jin, M.D.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.

**PMID:** 26830752

**Citation:** Lin QJ, Yang F, Jin C, Fu DL. Current status and progress of pancreatic cancer in China. World J Gastroenterol. 2015 Jul 14;21(26):7988-8003. doi: 10.3748/wjg.v21.i26.7988.

**PMID:** 26185370

**Citation:** Henrikson NB, Aiello Bowles EJ, Blasi PR, Morrison CC, Nguyen M, Pillarisetty VG, Lin JS. Screening for Pancreatic Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Aug 6;322(5):445-454. doi: 10.1001/jama.2019.6190.

**PMID:** 31386140

**Citation:** Singhi AD, Koay EJ, Chari ST, Maitra A. Early Detection of Pancreatic Cancer: Opportunities and Challenges. Gastroenterology. 2019 May;156(7):2024-2040. doi: 10.1053/j.gastro.2019.01.259. Epub 2019 Feb 2.

**PMID:** 30721664

**Citation:** Pereira SP, Oldfield L, Ney A, Hart PA, Keane MG, Pandol SJ, Li D, Greenhalf W, Jeon CY, Koay EJ, Almario CV, Halloran C, Lennon AM, Costello E. Early detection of pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Jul;5(7):698-710. doi: 10.1016/S2468-1253(19)30416-9. Epub 2020 Mar 2.

**PMID:** 32135127

**Citation:** Maitra A, Sharma A, Brand RE, Van Den Eeden SK, Fisher WE, Hart PA, Hughes SJ, Mather KJ, Pandol SJ, Park WG, Feng Z, Serrano J, Rinaudo JAS, Srivastava S, Chari ST; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas. 2018 Nov/Dec;47(10):1244-1248. doi: 10.1097/MPA.0000000000001169.

**PMID:** 30325864

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M13115

- Name: Pancreatitis

- Relevance: HIGH

- As Found: Pancreatitis

- ID: M26260

- Name: Pancreatitis, Chronic

- Relevance: HIGH

- As Found: Chronic Pancreatitis

- ID: M20441

- Name: Neoplasms, Cystic, Mucinous, and Serous

- Relevance: HIGH

- As Found: Cystic Neoplasms

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: T2768

- Name: Hereditary Pancreatitis

- Relevance: HIGH

- As Found: Hereditary Pancreatitis

- ID: T2243

- Name: Familial Pancreatic Cancer

- Relevance: HIGH

- As Found: Familial Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

- ID: D000018297

- Term: Neoplasms, Cystic, Mucinous, and Serous

- ID: D000010195

- Term: Pancreatitis

- ID: D000050500

- Term: Pancreatitis, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M207501

- Name: Chrysarobin

- Relevance: LOW

- As Found: Unknown

- ID: M22554

- Name: Pancrelipase

- Relevance: LOW

- As Found: Unknown

- ID: M13114

- Name: Pancreatin

- Relevance: LOW

- As Found: Unknown

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
