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Histopathological Changes in Mycosis Fungoides

Primary Purpose

Mycosis Fungoides

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
biopsy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mycosis Fungoides focused on measuring mycosis fungoides, histopathology

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histopathologically confirmed mycosis fungoides stage 1A patients Exclusion Criteria: Mycosis fungoides patients with other stages

Sites / Locations

  • Bezmialem Vakif University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lesional skin

non-lesional skin

Arm Description

lesional skin of mycosis fungoides stage 1A patients

non-lesional skin of mycosis fungoides stage 1A patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
June 6, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05904522
Brief Title
Histopathological Changes in Mycosis Fungoides
Official Title
Evaluation of Histopathological Changes in the Non-lesional Skin of Stage 1A Mycosis Fungoides Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides
Keywords
mycosis fungoides, histopathology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lesional skin
Arm Type
Experimental
Arm Description
lesional skin of mycosis fungoides stage 1A patients
Arm Title
non-lesional skin
Arm Type
Experimental
Arm Description
non-lesional skin of mycosis fungoides stage 1A patients
Intervention Type
Diagnostic Test
Intervention Name(s)
biopsy
Intervention Description
biopsy for histopathological examination
Primary Outcome Measure Information:
Title
CD4+ T cells in epidermis
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed mycosis fungoides stage 1A patients Exclusion Criteria: Mycosis fungoides patients with other stages
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer Mert
Phone
+905396778884
Email
omermert95@gmail.com
Facility Information:
Facility Name
Bezmialem Vakif University Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Mert
Phone
+905396778884
Email
omermert95@gmail.com
First Name & Middle Initial & Last Name & Degree
Ömer Mert
First Name & Middle Initial & Last Name & Degree
Özlem Su Küçük

12. IPD Sharing Statement

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Histopathological Changes in Mycosis Fungoides

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