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

February 5, 2024 updated by: Nourhan Emad, Cairo University

Assessment of the Tissue and Serum Level of NLRP1, NLRP3 Inflammasomes and Interleukin-18 in Early Stages of Mycosis Fungoids Patients Before and After Different Treatment Modalities: Controlled Clinical Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 14 early mycosis fungoids patients
Puva (psoralin and uva) Measure nlrp1 and nlrp3 and il18
Device: Puva (psoralin and uva )
Intervention will be given for 48 sessions or till coplete resolution of biopsied plaque
Other Names:
  • Methotrexate
  • Retinoids
Active Comparator: 8 mycosis fungoids patients
Puva (psoralin and uva) and methotrexate Measure nlrp1 and nlrp3 and il18
Device: Puva (psoralin and uva )
Intervention will be given for 48 sessions or till coplete resolution of biopsied plaque
Other Names:
  • Methotrexate
  • Retinoids
Active Comparator: Eight mycosis fungoids patients
Puva (psoralin and uva)and retinoids (acetritin) Measure nlrp1 and nlrp3 and il18
Device: Puva (psoralin and uva )
Intervention will be given for 48 sessions or till coplete resolution of biopsied plaque
Other Names:
  • Methotrexate
  • Retinoids
No Intervention: Controls
Measure nlrp1 and nlrp3 and il18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls.
Time Frame: 4 months
Diagnostic
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients before and after different treatment modalities.
Time Frame: 4 months
Intervention of 48 sessions of puva alone or in addition to mtx or retinoids
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.
Time Frame: 4 months
Observational
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD_437_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared after paper submission

IPD Sharing Time Frame

Around 4 months

IPD Sharing Access Criteria

nourhanemad921@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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