NCT05797493 Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
| NCT ID | NCT05797493 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-10-04 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The scope of the PICASSO project is to apply an innovative patient-based pan-omic approach to immune-assays, that will include multi-omics tumour characterization (genome, proteome, transcriptome), blood immune-cells and cytokine profiling, serological screening for paraneoplastic autoantibodies, clinical and metabolic measurements. The PICASSO project is aimed to validate in real world population the predictive role of SCLC transcriptomic classification (particularly, I-SCLC subtype) and to explore correlations with dynamic changes in peripheral blood immunity. Additionally, investigators expected to validate the predictive/prognostic role of emerging new variables, including metabolic-induced meta-inflammation alterations and subclinical auto-immunity.
Eligibility Criteria
Inclusion Criteria: 1. histologically- or cytologically-documented extensive-stage SCLC 2. to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors 3. No evidence of brain metastases at diagnosis 4. ECOG PS 0-2 5. adult patients (aged ≥ 18 years) at diagnosis; 6. signing of informed consent approved by the local Ethic Committee Exclusion Criteria: * none
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05797493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05797493 currently recruiting?
Yes, NCT05797493 is actively recruiting participants. Contact the research team at emilio.bria@policlinicogemelli.it for enrollment information.
Where is the NCT05797493 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05797493 clinical trial?
NCT05797493 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 100 participants.
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