Estimation of the Tissue and Serum Levels of Interleukin (IL) -35 in Mycosis Fungoides: a Case Control Study

Recruiting

• Conditions: Mycosis Fungoides
• Interventions: Diagnostic Test: Skin biopsy

• Registration Number: NCT05855460
• Lead Sponsor: Cairo University

Brief Summary

Tissue and serum samples from 20 MF patients and 20 normal healthy controls will be subjected for biochemical assessments by ELISA (Enzyme- linked immune-sorbent assay) for assessing the level of IL35.

Detailed Description

Tissue and serum samples from 20 MF patients and 20 normal healthy controls will be subjected for biochemical assessments by ELISA (Enzyme- linked immune-sorbent assay) for assessing the level of IL35

Study Timeline

• Study Start: 2023-01-12
• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with mycosis fungoides. Both genders. Age group ≥ 18 years old.

Exclusion Criteria

• Patients with any other skin diseases. Patients who received treatments for mycosis fungoides in the past three months.

Subjects with history of solid or hematological malignancy as leukemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mycosis fungoides patients	Skin biopsy	Blood sample and skin biopsy for assessment of IL35 by ELISA
Normal healthy controls	Skin biopsy	Blood sample and skin biopsy for assessment of IL35 levels by ELISA

Primary Outcome Measures

Name	Time	Method
To assess and compare tissue and serum levels of interleukin 35 (IL -35) in mycosis fungoides patients and normal controls.	1 year	To assess and compare tissue and serum levels of interleukin 35 (IL -35) in mycosis fungoides patients and normal controls.

Secondary Outcome Measures

Name	Time	Method
Correlating tissue and serum levels of IL-35 in mycosis fungoides patients with patients age, sex, duration, extent and stage of the disease. L	1 year	Correlating tissue and serum levels of IL-35 in mycosis fungoides patients with patients age, sex, duration, extent and stage of the disease.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt