Histopathological Changes in Mycosis Fungoides

February 12, 2024 updated by: Bezmialem Vakif University

Evaluation of Histopathological Changes in the Non-lesional Skin of Stage 1A Mycosis Fungoides Patients

Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

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

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Bezmialem Vakif University Hospital
        • Contact:
        • Principal Investigator:
          • Ömer Mert
        • Sub-Investigator:
          • Özlem Su Küçük

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

No

Description

Inclusion Criteria:

  • Histopathologically confirmed mycosis fungoides stage 1A patients

Exclusion Criteria:

  • Mycosis fungoides patients with other stages

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lesional skin
lesional skin of mycosis fungoides stage 1A patients
Diagnostic test: biopsy
biopsy for histopathological examination
Experimental: non-lesional skin
non-lesional skin of mycosis fungoides stage 1A patients
Diagnostic test: biopsy
biopsy for histopathological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4+ T cells in epidermis
Time Frame: 6 months
Histopathologically clonal T lymphocytes in epidermis reveal the diagnosis. If they are seen in non-lesional skin, then lesional specific local treatment is not enough for the disease.
6 months

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif 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)

May 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mf-E.84376

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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