Sarcoidosis Immunotsuppressive Therapy and Lymphoma Development

January 7, 2026 updated by: Mohamed Sabry, Alexandria University

Impact of Immunosuppressive Therapy of Sarcoidosis on Lymphoma Development

Impact of Immunosuppressive Therapy for Sarcoidosis on Lymphoma Development

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational cohort study to be conducted in the Chest Diseases Department, Alexandria Main University Hospital. A total of 40 adult patients (≥16 years) with biopsy-proven sarcoidosis will be consecutively recruited between December 2024 and December 2025. All patients will be either newly starting or continuing immunosuppressive therapy for sarcoidosis. The treatment regimen-systemic corticosteroids, conventional steroid-sparing agents (methotrexate, azathioprine, or mycophenolate), or biologics (anti-TNF agents)-will be recorded but not altered by study design. Each patient will be followed prospectively for 12 months from enrollment.

Study Type

Observational

Enrollment (Actual)

40

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

  • Egypt
    • Asafra
      • Alexandria, Asafra, Egypt, 11511
        • Alexandria main university hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Prospective cohort

Description

Inclusion Criteria:

  • Inclusion criteria include adult patients (≥18 years) with histologically confirmed sarcoidosis, receiving or planned to receive immunosuppressive therapy

Exclusion Criteria:Patients with a prior history of lymphoma or other active malignancy, HIV infection, or other primary immunodeficiency will be excluded.

-

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
Intervention / Treatment
Inclusion criteria include adult patients (≥16 years) with histologically confirmed sarcoidosis, rec
This is a prospective observational cohort study to be conducted in the Chest Diseases Department, Alexandria Main University Hospital. A total of 40 adult patients (≥16 years) with biopsy-proven sarcoidosis will be consecutively recruited between December 2024 and December 2025. All patients will be either newly starting or continuing immunosuppressive therapy for sarcoidosis.
Procedure: lymph node biopsy
sarcoidosis diagnosis by lymph node biopsy excisiona or bronchoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be incident, biopsy-proven lymphoma during the 12-month follow-up.
Time Frame: 12 MONTHS
LYMPH NODE BIOPSY EITHER EXCISIONAL OR BRONCHOSCOPIC
12 MONTHS
lymphoma development
Time Frame: 12 months
lymph node biopsy excisional or bronchoscopic
12 months

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Principal Investigator: ahmed mahmoud fawzy, professor, Alexandria University

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.

Helpful Links

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)

August 1, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alexandria U
  • Alexandria University (Other Identifier: alex main university hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not allowed in our department

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: statistics
    Information comments: pending

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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