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RecruitingNCT05904522Updated Feb 13, 2024

Histopathological Changes in Mycosis Fungoides

An interventional study of biopsy in Mycosis Fungoides, sponsored by Bezmialem Vakif University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mycosis Fungoides

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Keywords

  • mycosis fungoides
  • histopathology
03

In context

Mycosis Fungoides

447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.

This study's planned enrollment of 10 is below the median of 34 across 321 interventional studies indexed under Mycosis Fungoides.

Browse Mycosis Fungoides studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 356 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histopathologically confirmed mycosis fungoides stage 1A patients

Exclusion criteria

Exclusion Criteria:

  • Mycosis fungoides patients with other stages
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    lesional skin

    lesional skin of mycosis fungoides stage 1A patients

    Diagnostic Test: biopsy

  • Experimental
    non-lesional skin

    non-lesional skin of mycosis fungoides stage 1A patients

    Diagnostic Test: biopsy

Interventions

  • Diagnostic testbiopsy

    biopsy for histopathological examination

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Oct 2024, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2023
First posted
Jun 15, 2023
StartActual
May 1, 2023
Primary completionEst.
Oct 31, 2024
CompletionEst.
Oct 31, 2024
Last update
Feb 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05904522
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
May 1, 2023
Primary completion
Oct 31, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Feb 13, 2024

Study contacts

Ömer Mert
Contact
omermert95@gmail.com
+905396778884

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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