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

NCT ID: NCT05526638

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-05-30

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).

Conditions

Mycosis Fungoides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

New/ recurrent mycosis fungoides patients

New' Recurrent mycosis fungoides treatment will receive be assessed for both serum and tissue levels of IL-15 and IL-15 Rα prior to and after treatment with phototherapy

Group Type: EXPERIMENTAL

ultraviolet phototherapy

Intervention Type: RADIATION

thrice weekly sessions of ultraviolet phototherapy

Interventions

ultraviolet phototherapy

thrice weekly sessions of ultraviolet phototherapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rania Mogawer

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randa Youssef, MD

Role: STUDY_CHAIR

Cairo University

Locations

Cutaneous Lymphoma clinic, Cairo university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nourhan Emad, MSc

Role: CONTACT

nourhanemad693@gmail.com

01100709360

Rania Mogawer, MD

Role: CONTACT

raniamogawer@kasralainy.edu.eg

01068165330

Facility Contacts

Nourhan Emad, MSc

Role: primary

nourhanemad693@gmail.com

01100709360

Rania Mogawer, MD

Role: backup

raniamogawer@kasralainy.edu.eg

01068165330

Other Identifiers

MF-6-22

Identifier Type: -

Identifier Source: org_study_id