Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)

Sarcoidosis Clinical Trial

Official title:

Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234384
• Other study ID #: Pro00008556
• Status: Recruiting
• Start date: July 2013
• Est. completion date: July 2033

Study information

• Verified date: January 2024
• Source: Foundation for Sarcoidosis Research
• Contact: Leslie Serhuck, MD MA Mbioethics
• Phone: 312-341-0500
• Email: info[@]stopsarcoidosis.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of the study is to create a longitudinal study of patient reported outcomes for people living with sarcoidosis that maintains privacy. Patients report on the following: demographics, disease symptoms, diagnostic journey, provider experience, disease treatment, and burden of disease. The goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.

Description:

Participants review a document, Understanding Your Participation, and check boxes on the Participant Informed Consent document that confirms they understand the risks/benefits of participation (or Assent if the patient is a minor age 7-18), they create an online account, and then are asked to complete the baseline survey questionnaire. Participants confirm they understand that their participation is completely voluntary, that their identifying information will be secured and encrypted, their private health information will be stored separately in a secure database. Their private information will never be shared with other people, unless its required by law. The registry may share de-identified information with researchers and other databases. Their personal information will be protected and not shared. They may choose to stop their participation at any time by contacting FSR. They are not required to fill out all the questions and can leave any unanswered. They will be contacted by the registry once a year to update or correct their health information. They can choose to be contacted by FSR if a study becomes available that they may wish to know more about.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6647
• Est. completion date: July 2033
• Est. primary completion date: June 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

1. English speaking

2. Consent

3. Sarcoidosi diagnosis - Exclusion Criteria: NONE

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• Sarcoidosis diagnosis
Participants have been diagnosed with sarcoidosis.

Locations

Country	Name	City	State
United States	Foundation For Sarcoidosis Research	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Sarcoidosis Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completed participation in baseline survey	Baseline survey completion	If a survey question is completely blank, a query can be sent to request the subject to complete the section. Subjects will be contacted only twice to attempt to resolve an issue. The timeframe from time to event outcome shall not exceed 6 months.