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

May 3, 2023 updated by: Maha Fathy Elmasry, Cairo University

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo University
        • Contact:
        • Sub-Investigator:
          • Yasmine Obaid, Resident
        • Sub-Investigator:
          • Zeinab Nour, MD

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

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

Description

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 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
Mycosis fungoides patients
Blood sample and skin biopsy for assessment of IL35 by ELISA
Diagnostic test: Skin biopsy
biochemical assessment for measurement IL35 by ELISA (Enzyme linked immunosorbent assay) technique in tissue and serum samples of all thirty patients and healthy controls.
Other Names:
  • Blood sample
Normal healthy controls
Blood sample and skin biopsy for assessment of IL35 levels by ELISA
Diagnostic test: Skin biopsy
biochemical assessment for measurement IL35 by ELISA (Enzyme linked immunosorbent assay) technique in tissue and serum samples of all thirty patients and healthy controls.
Other Names:
  • Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess and compare tissue and serum levels of interleukin 35 (IL -35) in mycosis fungoides patients and normal controls.
Time Frame: 1 year
To assess and compare tissue and serum levels of interleukin 35 (IL -35) in mycosis fungoides patients and normal controls.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlating tissue and serum levels of IL-35 in mycosis fungoides patients with patients age, sex, duration, extent and stage of the disease. L
Time Frame: 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.
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Maha Fathy Elmasry, MD, Cairo University

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)

January 12, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yasmfil35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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