SarcoidosisNCT03844698
Association Between Cancer and Sarcoidosis
An observational study of Sarcoidosis and Cancer, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to develop a clinical dataset of sarcoidosis patients with a diagnosis of cancer who are categorized by date of birth, sex, race/ethnicity, clinical information, laboratory and imaging information, time of sarcoidosis onset, cancer type and treatment, time of cancer diagnosis, stage and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Cancer
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2019to 16 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer who were seeking or receiving medical care at the University of Miami that satisfy the inclusion and exclusion criteria of study are eligible to participate.
Who may be able to join
- Clinical diagnosis of Sarcoidosis following cancer
- Granulomatous reaction must be proven by pathology
Who cannot join
- . Aged younger than 18 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Outcome Study of Sarcoidosis: a New Paraneoplastic Syndrome in Patient With Cancer
The purpose of this study is to develop a clinical dataset of sarcoidosis patients with a diagnosis of cancer who are categorized by date of birth, sex, race/ethnicity, clinical information, laboratory and imaging information, time of sarcoidosis onset, cancer type and treatment, time of cancer diagnosis, stage and grade.
- Conditions
- Sarcoidosis, Cancer
- Keywords
- sarcoidosis, cancer, paraneoplastic, treatment, outcome
- Medical subject headings
- Sarcoidosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sarcoidosis and Cancer | These group of patients have a diagnosis of Sarcoidosis and Cancer on the Pathological Report. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology Proven Sarcoidosis In Patients with Cancer
Number of Participants With Sarcoidosis Events as Assessed by Positive Granulomatous Reaction in the Biopsies of Lung, Mediastinal Lymph Nodes, or Other Organs After Cancer Diagnosis.
Measured: up to 10 years
Secondary outcomes (2)
Cancer Cytogenetics and Sarcoidosis
Number of Participants With Sarcoidosis Events as Assessed by Cancer Cytogenetic Profiles of Cancer.
Measured: up to 10 years
Treatment Requirement of Sarcoidosis
Number of Participants With Sarcoidosis Events as Assessed by Requirement of Treatment with Steroid or Other Anti-Sarcoid Medications in Patients with Cancer.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start4 Jul 2019
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi Mirsaeidi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844698
- Sponsor's protocol ID
- 20180852
- Status last verified
- Apr 2022
- First submitted
- 11 Feb 2019
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murthi M, Yoshioka K, Cho JH, Arias S, Danna E, Zaw M, Holt G, Tatsumi K, Kawasaki T, Mirsaeidi M. Presence of concurrent sarcoid-like granulomas indicates better survival in cancer patients: a retrospective cohort study. ERJ Open Res. 2020 Oct 26;6(4):00061-2020. doi: 10.1183/23120541.00061-2020. eCollection 2020 Oct.
PubMed 33263026
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study of Sarcoidosis: a New Paraneoplastic Syndrome in Patient With Cancer
- ClinicalTrials.gov ID
- NCT03844698
- Acronym / sponsor ID
- 20180852
- Conditions
- Sarcoidosis, Cancer
- Keywords
- sarcoidosis, cancer, paraneoplastic, treatment, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 18 Feb 2019 (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 purpose of this study is to develop a clinical dataset of sarcoidosis patients with a diagnosis of cancer who are categorized by date of birth, sex, race/ethnicity, clinical information, laboratory and imaging information, time of sarcoidosis onset, cancer type and treatment, time of cancer diagnosis, stage and grade.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sarcoidosis and Cancer | – | –These group of patients have a diagnosis of Sarcoidosis and Cancer on the Pathological Report. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer who were seeking or receiving medical care at the University of Miami that satisfy the inclusion and exclusion criteria of study are eligible to participate.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Sarcoidosis following cancer
- Granulomatous reaction must be proven by pathology
Key exclusion criteria (1 listed)
- . Aged younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathology Proven Sarcoidosis In Patients with Cancer
Time frame: up to 10 years
Number of Participants With Sarcoidosis Events as Assessed by Positive Granulomatous Reaction in the Biopsies of Lung, Mediastinal Lymph Nodes, or Other Organs After Cancer Diagnosis.
2 secondary outcomes
Cancer Cytogenetics and Sarcoidosis
Time frame: up to 10 years
Treatment Requirement of Sarcoidosis
Time frame: up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 33263026Murthi M, Yoshioka K, Cho JH, Arias S, Danna E, Zaw M, Holt G, Tatsumi K, Kawasaki T, Mirsaeidi M. Presence of concurrent sarcoid-like granulomas indicates better survival in cancer patients: a retrospective cohort study. ERJ Open Res. 2020 Oct 26;6(4):00061-2020. doi: 10.1183/23120541.00061-2020. eCollection 2020 Oct.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mehdi Mirsaeidi, MD principal investigator
University of Miami
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 and Cancer, run by University of Miami 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 2 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: finished, as of the sponsor's last update on 4 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology Proven Sarcoidosis In Patients with Cancer (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844698, which also lists 1 linked publication.
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 4 May 2022.