## Protocol Section
### Identification Module
**NCT ID:** NCT00869479

**Brief Title:** Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

**Official Title:** Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

#### Organization Study ID Info
**ID:** 2008P002371
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-12-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-12-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Start Date
**Date:** 2009-03

**Status Verified Date:** 2010-12

#### Study First Post Date
**Date:** 2009-03-26
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-17
**Study First Submit QC Date:** 2009-03-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Old Name Title:** Alexandra Kimball, MD

**Old Organization:** Massachusetts General Hospital

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin.

### Conditions Module

**Conditions:**

- Nephrogenic Systemic Fibrosis

**Keywords:**

- Nephrogenic Systemic Fibrosis

- Screening

### Design Module

#### Design Info

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subjects with a histologically-proven diagnosis of NSF

**Label:** 1

#### Arm Group 2

**Description:** subjects with other fibrosing skin diseases

**Label:** 2

#### Arm Group 3

**Description:** subjects with non-fibrosing skin diseases

**Label:** 3

#### Arm Group 4

**Description:** subjects without skin diseases

**Label:** 4

### Outcomes Module

#### Primary Outcomes

**Measure:** Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases.

**Time Frame:** 1 day

#### Secondary Outcomes

**Measure:** Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases.

**Time Frame:** 1 day

**Measure:** Sensitivity of the questionnaire when applied to NSF subjects.

**Time Frame:** 1 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male or female subjects 18 years of age or older.
2. Willing and able to understand and provide oral informed consent.
3. Able to complete study and comply with study procedures.

Exclusion Criteria:

1. Subject is unable to provide oral consent.
2. Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Massachusetts General Hospital Dermatology and Rheumatology clinics

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital

**State:** Massachusetts

**Zip:** 02114

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Jonathan Kay, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Todd DJ, Kay J. Nephrogenic systemic fibrosis: an epidemic of gadolinium toxicity. Curr Rheumatol Rep. 2008 Jul;10(3):195-204. doi: 10.1007/s11926-008-0033-6.

**PMID:** 18638427

**Citation:** Todd DJ, Kagan A, Chibnik LB, Kay J. Cutaneous changes of nephrogenic systemic fibrosis: predictor of early mortality and association with gadolinium exposure. Arthritis Rheum. 2007 Oct;56(10):3433-41. doi: 10.1002/art.22925.

**PMID:** 17907148

**Citation:** Lima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877.

**PMID:** 23097320

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Fibrosis

- ID: M27988

- Name: Nephrogenic Fibrosing Dermopathy

- Relevance: HIGH

- As Found: Nephrogenic Systemic Fibrosis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4073

- Name: Nephrogenic Systemic Fibrosis

- Relevance: HIGH

- As Found: Nephrogenic Systemic Fibrosis

### Condition Browse Module - Meshes

- ID: D000054989

- Term: Nephrogenic Fibrosing Dermopathy

- ID: D000005355

- Term: Fibrosis

### Misc Info Module

- Version Holder: 2024-05-24
