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

NCT05855460 | Unknown

• 1 other identifier: Yasmfil35
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• To assess and compare tissue and serum levels of interleukin 35 (IL -35) in mycosis fungoides patients and normal controls.

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

  1 year

Secondary Outcomes (1)

• 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

Study Arms (2)

Mycosis fungoides patients

Blood sample and skin biopsy for assessment of IL35 by ELISA

Diagnostic Test: Skin biopsy

Normal healthy controls

Blood sample and skin biopsy for assessment of IL35 levels by ELISA

Diagnostic Test: Skin biopsy

Interventions

Skin biopsy DIAGNOSTIC_TEST

biochemical assessment for measurement IL35 by ELISA (Enzyme linked immunosorbent assay) technique in tissue and serum samples of all thirty patients and healthy controls.

Also known as: Blood sample

Mycosis fungoides patients; Normal healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with mycosis fungoides. Subjects attending plastic surgery units for abdominoplasty will be enrolled as controls.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maha Fathy Elmasry, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Doss, MD

CONTACT

01223283288; Sallydoss@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maha Fathy Elmasry, MD

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: January 12, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

EG (1)