NCT03844698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 4, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

2.2 years

First QC Date

February 11, 2019

Last Update Submit

April 27, 2022

Conditions

Keywords

sarcoidosis, cancer, paraneoplastic, treatment, outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cancer Cytogenetics and Sarcoidosis

    up to 10 years

  • Treatment Requirement of Sarcoidosis

    up to 10 years

Study Arms (1)

Patients with Sarcoidosis and Cancer

These group of patients have a diagnosis of Sarcoidosis and Cancer on the Pathological Report.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Aged younger than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Pathological slides from patients, which contains Hematoxylin and Eosin ( H\&E) tissue stain fixation.

MeSH Terms

Conditions

SarcoidosisNeoplasms

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Mehdi Mirsaeidi, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 18, 2019

Study Start

July 4, 2019

Primary Completion

September 16, 2021

Study Completion

September 16, 2021

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations