Scleroderma Registry & Repository At the Hospital for Special Surgery

Study Purpose

The overall objective of the Scleroderma Registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the Hospital for Special Surgery (HSS). The registry facilitates our understanding of the clinical features, pathobiology, genetics of Scleroderma. This will ultimately lead to a potential treatment for this currently untreatable condition.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Individuals older than 18 years of age with Scleroderma.

Exclusion Criteria:

  • - Individuals younger than 18 years of age.
- Individuals older than 18 years of age without Scleroderma

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01656447
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital for Special Surgery, New York
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robert F Spiera, MDJessica K Gordon, MD
Principal Investigator Affiliation Hospital for Special Surgery, New YorkHospital for Special Surgery, New York
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scleroderma
Study Website: View Trial Website
Additional Details

What will be asked of you:

  • - Completion of 2 health questionnaires.
  • - Donation of research bloods.
This is optional, but encouraged (if possible).
  • - We also encourage patients who come for initial visits to return so follow-up data can be collected.
Benefits to Patients:
  • - The HSS Scleroderma Registry gives patients the opportunity to participate in observational research with the goal of improving the lives of patients in the future.
  • - By donating research bloods and providing clinical information, patients will help generate new knowledge about Scleroderma that can guide the treatment and care of patients afflicted with this rare disease.
  • - Patients will also receive a comprehensive, medical evaluation from an HSS physician who specializes in treating Scleroderma.
He or she will provide guidance on treatment options and recommendations for current or upcoming clinical trials.
  • - Physicians will also make patients aware of the resources available to them, including support groups and educational programs.

Arms & Interventions

Arms

: Patients with Scleroderma

Patients who have been diagnosed at any point in their life with Scleroderma will compose the cohort.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Eliza Pelrine, BA

[email protected]

212-774-2123