SarcoidosisNCT06234384
Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)
An observational study of Sarcoidosis, run by Foundation for Sarcoidosis Research at 1 site in United States.
Trial summary
The goal of the study is to create a longitudinal record 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Sarcoidosis diagnosis
- How many people
- 6,833 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2033
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any adult or child (with a parent or legal guardian's assent) who has been given the diagnosis of sarcoidosis (including juvenile sarcoidosis or Blau Syndrome), and who are able to understand the consent form explaining the risks and benefits of participation.
Who may be able to join
- English speaking
- Consent
- Sarcoidosi diagnosis -
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Foundation For Sarcoidosis Research
Chicago, Illinois, 60654
Tricha Shivas, MBe, 312-241-0400, tricha@stopsarcoidosis.org
Rebecca A Epstein, MPH, 312-340-0500, rebecca@stopsarcoidosis.org
About this study
The goal of the study is to create a longitudinal record 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. Patients can also link their Electronic Health Records (EHR). The goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.
Read the detailed 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.
- Conditions
- Sarcoidosis
- Being tested
- Sarcoidosis diagnosis
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcoidosis diagnosisOther
Participants have been diagnosed with sarcoidosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed participation in baseline survey
Baseline survey completion
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study startJul 2013
- Primary completionJun 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,833 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Foundation for Sarcoidosis Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234384
- Sponsor's protocol ID
- Pro00008556
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient data is de-identified, researchers can request access to de-identified data only.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)
- ClinicalTrials.gov ID
- NCT06234384
- Acronym / sponsor ID
- Pro00008556
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,833 participants (estimated)
- Lead sponsor
- Foundation for Sarcoidosis ResearchUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to create a longitudinal record 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. Patients can also link their Electronic Health Records (EHR). The goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any adult or child (with a parent or legal guardian's assent) who has been given the diagnosis of sarcoidosis (including juvenile sarcoidosis or Blau Syndrome), and who are able to understand the consent form explaining the risks and benefits of participation.
Key inclusion criteria (3 listed)
- English speaking
- Consent
- Sarcoidosi diagnosis -
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcoidosis diagnosisParticipants have been diagnosed with sarcoidosis. | Other | – |
Primary outcome
Completed participation in baseline survey
Time frame: 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.
Baseline survey completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. All patient data is de-identified, researchers can request access to de-identified data only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Foundation for Sarcoidosis Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie Serhuck, MD MA Mbioethics (312-341-0500, info@stopsarcoidosis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completed participation in baseline survey (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.