Clinical trial NCT05526638: Serum and Tissue Level of Interleukin-15 (IL-15) and IL-15 Receptor Alpha (IL-15Rα) in Mycosis Fungoides
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mycosis Fungoides
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort study
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: Assessing percent change in serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides
timeFrame: 6 months
measure: 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.
timeFrame: 4 months
measure: 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 controls
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of the use of serum levels of IL-15 and IL-15 Rα as markers for their tissue levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cutaneous Lymphoma clinic, Cairo university hospitals
Study officials:
affiliation: Cairo University
name: Randa Youssef, MD
role: STUDY_CHAIR
References: