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Association Between Cancer and Sarcoidosis

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ClinicalTrials.gov Identifier: NCT03844698
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Mehdi Mirsaeidi, University of Miami

Brief 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 grade.

Condition or disease
Sarcoidosis Cancer

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcome Study of Sarcoidosis: a New Paraneoplastic Syndrome in Patient With Cancer
Actual Study Start Date : July 4, 2019
Estimated Primary Completion Date : February 5, 2022
Estimated Study Completion Date : February 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cancer Cytogenetics and Sarcoidosis [ Time Frame: up to 10 years ]
    Number of Participants With Sarcoidosis Events as Assessed by Cancer Cytogenetic Profiles of Cancer.

  2. 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.


Biospecimen Retention:   Samples With DNA
Pathological slides from patients, which contains Hematoxylin and Eosin ( H&E) tissue stain fixation.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

. Aged younger than 18 years old.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844698


Contacts
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Contact: Mehdi Mirsaeidi, MD (305)243-9227 msm249@miami.edu
Contact: Camila Rodriguez (305)243-2568

Locations
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United States, Florida
University of Miami, Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Mehdi Mirsaeidi, MD    305-243-2568    msm249@miami.edu   
Contact: Adam Wanner, MD    (305)243-2568    awanner@med.miami.edu   
Principal Investigator: Mehdi Mirsaeidi, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Mehdi Mirsaeidi, MD University of Miami
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mehdi Mirsaeidi, Assistant Professor of Department of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT03844698    
Other Study ID Numbers: 20180852
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehdi Mirsaeidi, University of Miami:
sarcoidosis, cancer, paraneoplastic, treatment, outcome
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases