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

Mycosis Fungoides Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526638
• Other study ID #: MF-6-22
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: Nourhan Emad, MSc
• Phone: 01100709360
• Email: nourhanemad693[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides

Intervention

Radiation:
• ultraviolet phototherapy
thrice weekly sessions of ultraviolet phototherapy

Locations

Country	Name	City	State
Egypt	Cutaneous Lymphoma clinic, Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing percent change in serum and tissue levels of IL-15 and IL-15 Ra in cases of mycosis fungoides	Assessing percent change in serum and tissue levels of IL-15 and IL-15 Ra in cases of mycosis fungoides prior to starting phototherapy Assessing percent change in serum and tissue levels of IL-15 and IL-15 Ra in cases of mycosis fungoides prior to starting phototherapy and shortly after resolution of the biopsied lesion.	6 months
Primary	Assessing serum and tissue levels of IL-15 and IL-15 Ra 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 Ra in cases of mycosis fungoides prior to starting phototherapy in comparison to healthy controls	4 months
Primary	Assessing serum and tissue levels of IL-15 and IL-15 Ra 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 Ra in cases of mycosis fungoides shortly after resolution of the biopsied lesion in comparison to healthy controls	6 months
Secondary	Feasibility of the use of serum levels of IL-15 and IL-15 Ra as markers for their tissue levels	Correlating serum level of serum levels of IL-15 and IL-15 Ra with their tissue levels	6 months