Early Disease OnsetNCT06066554
Tissue and Serum Level of NLRP1, NLRP3 and Il-18 in Early Stages of mf Patients
A study testing Puva (psoralin and uva ) in people with Early Disease Onset, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Disease Onset
- What is being tested?
- Puva (psoralin and uva )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New patients with early stages of mycosis fungoids (patch and plaque stage).
- Both genders
- Age group ≥ 18 years old.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Puva (psoralin and uva )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puva (psoralin and uva )Device
Also called Methotrexate, Retinoids
Intervention will be given for 48 sessions or till coplete resolution of biopsied plaque
| Study group | Role | What they receive |
|---|---|---|
| 14 early mycosis fungoids patients | Active comparator | Puva (psoralin and uva) Measure nlrp1 and nlrp3 and il18 Receives: Device: Puva (psoralin and uva ) |
| 8 mycosis fungoids patients | Active comparator | Puva (psoralin and uva) and methotrexate Measure nlrp1 and nlrp3 and il18 Receives: Device: Puva (psoralin and uva ) |
| Eight mycosis fungoids patients | Active comparator | Puva (psoralin and uva)and retinoids (acetritin) Measure nlrp1 and nlrp3 and il18 Receives: Device: Puva (psoralin and uva ) |
| Controls | No intervention | Measure nlrp1 and nlrp3 and il18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare tissue and serum level of NLRP1, NLRP3 inflammasomes and Interleukin (IL)-18 in mycosis fungoids patients and normal controls.
Diagnostic
Measured: 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.
Intervention of 48 sessions of puva alone or in addition to mtx or retinoids
Measured: 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.
Observational
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start15 Feb 2024 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Disease OnsetStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Emad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066554
- Sponsor's protocol ID
- MD_437_2022
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after paper submission
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06066554
- Acronym / sponsor ID
- MD_437_2022
- Conditions
- Early Disease Onset
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 14 early mycosis fungoids patients | Active comparator | Device: Puva (psoralin and uva )Puva (psoralin and uva) Measure nlrp1 and nlrp3 and il18 |
| 8 mycosis fungoids patients | Active comparator | Device: Puva (psoralin and uva )Puva (psoralin and uva) and methotrexate Measure nlrp1 and nlrp3 and il18 |
| Eight mycosis fungoids patients | Active comparator | Device: Puva (psoralin and uva )Puva (psoralin and uva)and retinoids (acetritin) Measure nlrp1 and nlrp3 and il18 |
| Controls | No intervention | –Measure nlrp1 and nlrp3 and il18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New patients with early stages of mycosis fungoids (patch and plaque stage).
- Both genders
- Age group ≥ 18 years old.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puva (psoralin and uva )Also: Methotrexate, RetinoidsIntervention will be given for 48 sessions or till coplete resolution of biopsied plaque | Device | 14 early mycosis fungoids patients, 8 mycosis fungoids patients, Eight mycosis fungoids patients |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Yes. Data will be shared after paper submission
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Puva (psoralin and uva ) in people with Early Disease Onset, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.