The Scleroderma Biorepository and Pathogenesis Study (STO... | NCT02887495

Studies
The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)

NCT02887495

Sponsor

George Washington University

Status

Completed

Last Update Posted

Jul 27, 2022Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Scleroderma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Feb 2, 2022Actual

Completion Date

Feb 2, 2022Actual

First Submitted Date

Feb 3, 2015

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Sep 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2022

Last Update Posted Date

Jul 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Measure	Description	Time Frame
Modified Rodnan Skin Score		10 years

Measure	Description	Time Frame
Medsger Severity Score		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Able to give informed consent.
Diagnosed with scleroderma or with positive autoantibodies

Exclusion Criteria:

< 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with scleroderma, raynauds, or with positive autoantibodies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Victoria K Shanmugam, MD	The George Washington University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Victoria K Shanmugam		Washington D.C.	District of Columbia	20037	United States

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided