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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05855460
Collaborator
(none)
20
Enrollment
1
Location
4.6
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Skin biopsy

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Estimation of the Tissue and Serum Levels of Interleukin (IL) -35 in Mycosis Fungoides: a Case Control Study.
Actual Study Start Date :
Jan 12, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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]

      Correlating tissue and serum levels of IL-35 in mycosis fungoides patients with patients age, sex, duration, extent and stage of the disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Giza Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maha Fathy Elmasry, Maha Fathy Elmasry, MD, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05855460
    Other Study ID Numbers:
    • Yasmfil35
    First Posted:
    May 11, 2023
    Last Update Posted:
    May 11, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Mycosis Fungoides

    Study Results

    No Results Posted as of May 11, 2023