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NCT05904522 Clinical Trial

Histopathological Changes in Mycosis Fungoides

Mycosis Fungoides Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05904522
Other study ID # mf-E.84376
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date October 31, 2024

Study information
Verified date February 2024
Source Bezmialem Vakif University
Contact Ömer Mert
Phone +905396778884
Email omermert95@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Histopathologically confirmed mycosis fungoides stage 1A patients Exclusion Criteria: - Mycosis fungoides patients with other stages

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• biopsy
biopsy for histopathological examination

Locations
Country Name City State
Turkey Bezmialem Vakif University Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary CD4+ T cells in epidermis 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
See also
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