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Serum and Tissue Level of Interleukin-15 (IL-15) and IL-15 Receptor Alpha (IL-15Rα) in Mycosis Fungoides

Estimation of Serum and Tissue Level of Interleukin-15 (IL-15) and IL-15 Receptor Alpha (IL-15Rα) in Mycosis Fungoides Before and After Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05526638
Enrollment
15
Registered
2022-09-02
Start date
2023-01-01
Completion date
2023-05-30
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycosis Fungoides

Brief 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).

Interventions

RADIATIONultraviolet phototherapy

thrice weekly sessions of ultraviolet phototherapy

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

prospective cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessing serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides shortly after resolution of the biopsied lesion in comparison to healthy controls6 monthsAssessing serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides shortly after resolution of the biopsied lesion in comparison to healthy controls
Assessing percent change in serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides6 monthsAssessing percent change in serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides prior to starting phototherapy Assessing percent change in serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides prior to starting phototherapy and shortly after resolution of the biopsied lesion.
Assessing serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides prior to starting phototherapy in comparison to healthy controls.4 monthsAssessing serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides prior to starting phototherapy in comparison to healthy controls

Secondary

MeasureTime frameDescription
Feasibility of the use of serum levels of IL-15 and IL-15 Rα as markers for their tissue levels6 monthsCorrelating serum level of serum levels of IL-15 and IL-15 Rα with their tissue levels

Countries

Egypt

Contacts

Primary ContactNourhan Emad, MSc
nourhanemad693@gmail.com01100709360
Backup ContactRania Mogawer, MD
raniamogawer@kasralainy.edu.eg01068165330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026