NCT02887495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

7.6 years

First QC Date

February 3, 2015

Last Update Submit

July 25, 2022

Conditions

Scleroderma

Keywords

sclerodermabiorepository

Outcome Measures

Primary Outcomes (1)

  • Modified Rodnan Skin Score

    10 years

Secondary Outcomes (1)

  • Medsger Severity Score

    10 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with scleroderma, raynauds, or with positive autoantibodies

You may qualify if:

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

You may not qualify if:

  • \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria K Shanmugam

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Victoria K Shanmugam, MD

    The George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2015

First Posted

September 2, 2016

Study Start

July 1, 2014

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

US(1)