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

Primary Purpose

Mycosis Fungoides

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultraviolet phototherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mycosis Fungoides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cutaneous Lymphoma clinic, Cairo university hospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New/ recurrent mycosis fungoides patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

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

Full Information

First Posted
August 31, 2022
Last Updated
January 31, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05526638
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New/ recurrent mycosis fungoides patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
ultraviolet phototherapy
Intervention Description
thrice weekly sessions of ultraviolet phototherapy
Primary Outcome Measure Information:
Title
Assessing percent change in serum and tissue levels of IL-15 and IL-15 Rα in cases of mycosis fungoides
Description
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.
Time Frame
6 months
Title
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.
Description
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
Time Frame
4 months
Title
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
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Feasibility of the use of serum levels of IL-15 and IL-15 Rα as markers for their tissue levels
Description
Correlating serum level of serum levels of IL-15 and IL-15 Rα with their tissue levels
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nourhan Emad, MSc
Phone
01100709360
Email
nourhanemad693@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Mogawer, MD
Phone
01068165330
Email
raniamogawer@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa Youssef, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cutaneous Lymphoma clinic, Cairo university hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nourhan Emad, MSc
Phone
01100709360
Email
nourhanemad693@gmail.com
First Name & Middle Initial & Last Name & Degree
Rania Mogawer, MD
Phone
01068165330
Email
raniamogawer@kasralainy.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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