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

NCT ID: NCT06066554

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-05-30

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.

Detailed Description

Thirty patients with early stage mycosis fungoids and thirty normal healthy controls will be recruited. An informed written consent will be obtained from all patients and controls.

Data collection Demographic data Each patient will be subjected to detailed history taking as regards age, sex, residence, marital status, smoking, special habits of medical importance, duration of the disease, associated diseases, previous therapy and family history.

Evaluation of the clinical response The patients will be photographed and evaluated at baseline and at the end of treatment .

Clinical scoring of five mycosis fungoids skin lesions will be done using Composite assessment of index lesion severity (CAILS) (Oslen et al., 2011).

Clinical scoring of whole body affection will be done using Modified Severity Weighted Assessment tool (MSWAT) (Oslen et al., 2011).

Assessment of response of mycosis fungoids patients to our treatment modalities will be done using Objective response rate (ORR) (Oslen et al., 2011).

Treatment (therapeutic intervention):

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 End of the study will be defined as achieving clinically near complete clearance of the lesion from which a tissue biopsy will be taken or a maximum of 48 sessions of treatment.

Biochemical assessment and pathological assessment (Diagnostic intervention) :

Two lesional skin 4 mm punch biopsies will be taken from same lesion in all thirty patients and once from all thirty normal healthy controls.

Three milliliter serum samples will be taken from all thirty patient before and after treatment and once from all thirty healthy controls.

one skin biopsy and serum samples before treatment will be subjected to biochemical assessment for measurement of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 by ELISA (Enzyme linked immunosorbent assay) technique.

The other skin biopsy will be used for pathological assessment. The same process will be repeated after treatment for patients only to assess the percent change in all parameters and in lymphocytic infiltration .

Fate of tissue and serum samples Tissue samples used for biochemical assessment will be completely crushed to extract protein for ELISA, any residual biological tissue will be safely discarded in the incinerator.

Tissue samples used for pathological assessment will be put on paraffin blocks then on slides that will be kept in our department.

Serum samples will be collected in special containers to be sent to the official site in the hospital to get rid of them.

Intervention:

Diagnostic intervention : biochemical assessment for measurement of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 by ELISA (Enzyme linked immunosorbent assay) technique in tissue and serum samples of all thirty patients and healthy controls.

Therapeutic intervention : 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

Conditions

Early Disease Onset

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

14 early mycosis fungoids patients

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

Group Type: ACTIVE_COMPARATOR

Puva (psoralin and uva )

Intervention Type: DEVICE

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

8 mycosis fungoids patients

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

Group Type: ACTIVE_COMPARATOR

Puva (psoralin and uva )

Intervention Type: DEVICE

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

Eight mycosis fungoids patients

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

Group Type: ACTIVE_COMPARATOR

Puva (psoralin and uva )

Intervention Type: DEVICE

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

Controls

Measure nlrp1 and nlrp3 and il18

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Puva (psoralin and uva )

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

Intervention Type: DEVICE

Other Intervention Names

Methotrexate; Retinoids

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Emad

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MD_437_2022

Identifier Type: -

Identifier Source: org_study_id