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

NCT05526638 | Unknown DMC

• 1 other identifier: MF-6-22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Feasibility of the use of serum levels of IL-15 and IL-15 Rα as markers for their tissue levels

  6 months

Study Arms (1)

New/ recurrent mycosis fungoides patients

EXPERIMENTAL

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

Interventions

ultraviolet phototherapy RADIATION

thrice weekly sessions of ultraviolet phototherapy

New/ recurrent mycosis fungoides patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with mycosis fungoides; newly diagnosed or recurrent after cessation of treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cutaneous Lymphoma clinic, Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Randa Youssef, MD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Nourhan Emad, MSc

CONTACT

01100709360; nourhanemad693@gmail.com

Rania Mogawer, MD

CONTACT

01068165330; raniamogawer@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: prospective cohort study

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: January 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 12 months after article publication
• Access Criteria: Controlled Access: Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal.

Locations

EG (1)