NCT05526638

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
RADIATION	ultraviolet phototherapy	thrice weekly sessions of ultraviolet phototherapy

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-04-30
• Completion: 2023-05-30
• First posted: 2022-09-02
• Last updated: 2023-02-02

Locations

1 site across 1 country: Egypt