Impact of Immunosuppressive Therapy of Sarcoidosis on Lymphoma Development
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The primary outcome will be incident, biopsy-proven lymphoma during the 12-month follow-up.
Study Overview
Brief Summary
Impact of Immunosuppressive Therapy for Sarcoidosis on Lymphoma Development
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
lymphoma development
Time Frame: 12 months
lymph node biopsy excisional or bronchoscopic
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Sabry
lecturer
Alexandria University