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

Estimation of serum and tissue level of IL-15 and IL-15 R α in mycosis fungoides prior to after treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Mycosis Fungoides
• Intervention / Treatment: Radiation: ultraviolet phototherapy

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).

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan Emad, MSc; Phone Number: 01100709360; Email: nourhanemad693@gmail.com
• Study Contact Backup: Name: Rania Mogawer, MD; Phone Number: 01068165330; Email: raniamogawer@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cutaneous Lymphoma clinic, Cairo university hospitals
    • Contact: Nourhan Emad, MSc; Phone Number: 01100709360; Email: nourhanemad693@gmail.com
    • Contact: Rania Mogawer, MD; Phone Number: 01068165330; Email: raniamogawer@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: ultraviolet phototherapy; thrice weekly sessions of ultraviolet phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing percent change in serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides	Assessing 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.	6 months
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.	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 months
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	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the use of serum levels of IL-15 and IL-15 Rα as markers for their tissue levels	Correlating serum level of serum levels of IL-15 and IL-15 Rα with their tissue levels	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Randa Youssef, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Bacterial Infections and Mycoses; Lymphoma; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Mycoses; Mycosis Fungoides
• Other Study ID Numbers: MF-6-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Participants' data that underlie reported results will be shared upon request, after deidentification
• IPD Sharing Time Frame: Beginning 3 months and ending 12 months after article publication

IPD Sharing Access Criteria

Controlled Access:

Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No