Histopathological Changes in Mycosis Fungoides

NCT05904522 | Recruiting

• 1 other identifier: mf-E.84376
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mycosis Fungoides

Keywords

mycosis fungoides; histopathology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

lesional skin

EXPERIMENTAL

lesional skin of mycosis fungoides stage 1A patients

Diagnostic Test: biopsy

non-lesional skin

EXPERIMENTAL

non-lesional skin of mycosis fungoides stage 1A patients

Diagnostic Test: biopsy

Interventions

biopsy DIAGNOSTIC_TEST

biopsy for histopathological examination

lesional skin; non-lesional skin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed mycosis fungoides stage 1A patients

You may not qualify if:

• Mycosis fungoides patients with other stages

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Biopsy

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)

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

Central Study Contacts

Ömer Mert

CONTACT

+905396778884; omermert95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination. Lesional skin of the patient will be compared with the non-lesional skin of the same patient.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: May 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)