Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06066554 |
| Other study ID # |
MD_437_2022 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2024 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
