Association Between Cancer and Sarcoidosis

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: Cancer; Sarcoidosis

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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	Number of Participants With Sarcoidosis Events as Assessed by Cancer Cytogenetic Profiles of Cancer.	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.	up to 10 years

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

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: sarcoidosis, cancer, paraneoplastic, treatment, outcome
• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis
• 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