To hear about similar clinical trials, please enter your email below
Trial Title:
Serum and Tissue Level of Interleukin-15 (IL-15) and IL-15 Receptor Alpha (IL-15Rα) in Mycosis Fungoides
NCT ID:
NCT05526638
Condition:
Mycosis Fungoides
Conditions: Official terms:
Mycoses
Mycosis Fungoides
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
prospective cohort study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
ultraviolet phototherapy
Description:
thrice weekly sessions of ultraviolet phototherapy
Arm group label:
New/ recurrent mycosis fungoides patients
Summary:
Estimation of serum and tissue level of IL-15 and IL-15 R α in mycosis fungoides prior to
after treatment.
Detailed description:
Twenty patients will be recruited from the cutaneous lymphoma clinic who are either
recently diagnosed with MF or presenting with recurrent MF following cessation of
treatment.
An informed written consent will be obtained from all patients. Clinical assessment:
Patients will be assessed clinically for extent by BSA as well as MF staging and type.
For MF staging, in addition to extent, diagnostic skin biopsies will be assessed for
depth of the infiltrate. Radiological assessment including chest x-ray, pelvi-abdominal
ultrasound as well as lymph node examination, ultrasound and biopsy if required.
Biochemical assessment including complete blood count, liver and kidney function tests,
lipid profile as well as lactate dehydrogenase and beta 2 microglobulin.
Standardized photographs will be taken at initial assessment as well as following
resolution of the biopsied lesion.
Baseline biochemical assessment at the beginning of the study: Serum samples as well as
4mm lesional punch skin biopsies will be taken prior to starting phototherapy treatment
to assess serum and tissue level of IL-15 and IL-15 R α level using enzyme-linked
immunosorbent assay (ELISA).
Phototherapy treatment: Patients with superficial lymphocytic infiltrate will be assigned
to either NB-UVB sessions, while those with deep infiltrate will be assigned to PUVA.
Patients will undergo thrice weekly sessions.
Patients will be clinically assessed on monthly basis to monitor response to treatment
and record any side effects.
Biochemical reassessment: Serum and lesional biopsies will be retaken following
resolution of the biopsied lesion to assess serum and tissue level of IL-15 and IL-15 R α
level using enzyme-linked immunosorbent assay (ELISA).
Afterwards, the biopsied lesion will be covered if the patients was having other
unresolved lesions and monthly follow up will be carried to detect lesional recurrence.
Any reported recurrence during the estimated study duration of 6 months will be re
assessed for both serum and tissue level of IL-15 and IL-15 R α level using enzyme-linked
immunosorbent assay (ELISA).
Twenty healthy controls will be recruited and assessed for both serum and tissue level of
IL-15 and IL-15 R α level using enzyme-linked immunosorbent assay (ELISA).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of
treatment
Exclusion Criteria:
- Patients with any contraindication to phototherapy (e.g., any other skin cancers or
photosensitivity); or to psoralen (e.g., liver disease).
- Subjects with history of solid or hematological malignancy as leukemia.
- Patients with autoimmune disease as SLE.
- Patients who received treatment for the past one month.
- Pregnant and lactating females.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cutaneous Lymphoma clinic, Cairo university hospitals
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nourhan Emad, MSc
Phone:
01100709360
Email:
nourhanemad693@gmail.com
Contact backup:
Last name:
Rania Mogawer, MD
Phone:
01068165330
Email:
raniamogawer@kasralainy.edu.eg
Start date:
January 1, 2023
Completion date:
May 30, 2023
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05526638