Tissue and Serum Level of NLRP1, NLRP3 and Il-18 in Early Stages of mf Patients

NCT06066554 | Not Yet Recruiting DMC

• 1 other identifier: MD_437_2022
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls. To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients before and after different treatment modalities.

Conditions

Early Disease Onset

Outcome Measures

Primary Outcomes (1)

• To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls.

  Diagnostic

  4 months

Secondary Outcomes (2)

• To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients before and after different treatment modalities.

  4 months

• Correlating tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients with patient's age, sex, duration of disease, extent of disease.

  4 months

Study Arms (4)

14 early mycosis fungoids patients

ACTIVE COMPARATOR

Puva (psoralin and uva) Measure nlrp1 and nlrp3 and il18

Device: Puva (psoralin and uva )

8 mycosis fungoids patients

ACTIVE COMPARATOR

Puva (psoralin and uva) and methotrexate Measure nlrp1 and nlrp3 and il18

Device: Puva (psoralin and uva )

Eight mycosis fungoids patients

ACTIVE COMPARATOR

Puva (psoralin and uva)and retinoids (acetritin) Measure nlrp1 and nlrp3 and il18

Device: Puva (psoralin and uva )

Controls

NO INTERVENTION

Measure nlrp1 and nlrp3 and il18

Interventions

Puva (psoralin and uva ) DEVICE

Intervention will be given for 48 sessions or till coplete resolution of biopsied plaque

Also known as: Methotrexate, Retinoids

14 early mycosis fungoids patients; 8 mycosis fungoids patients; Eight mycosis fungoids patients

Eligibility Criteria

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

You may qualify if:

• New patients with early stages of mycosis fungoids (patch and plaque stage).
• Both genders
• Age group ≥ 18 years old.

You may not qualify if:

• Patients with late stages mycosis fungoids (Tumor stage).
• Patients with absolute 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 (e.g. SLE).
• Patients who received treatment of mycosis fungoids for the past one month.
• Pregnant and lactating females.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Photochemotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Thirty new patients with early stage mycosis fungoids will be allocated to proper treatment modality that differ according to the patient's clinical state following kasralainy phototherapy unit protocol

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: February 15, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 30, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Around 4 months
• Access Criteria: nourhanemad921@gmail.com