Association Between Cancer and Sarcoidosis

April 27, 2022 updated by: University of Miami

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Miller School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Clinical diagnosis of Sarcoidosis following cancer
  • Granulomatous reaction must be proven by pathology

Exclusion Criteria:

. Aged younger than 18 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Sarcoidosis and Cancer
These group of patients have a diagnosis of Sarcoidosis and Cancer on the Pathological Report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Cytogenetics and Sarcoidosis
Time Frame: up to 10 years
Number of Participants With Sarcoidosis Events as Assessed by Cancer Cytogenetic Profiles of Cancer.
up to 10 years
Treatment Requirement of Sarcoidosis
Time Frame: up to 10 years
Number of Participants With Sarcoidosis Events as Assessed by Requirement of Treatment with Steroid or Other Anti-Sarcoid Medications in Patients with Cancer.
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Mehdi Mirsaeidi, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2019

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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