Small Cell Lung CancerPICASSONCT05797493
Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
An observational study of Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Atezolizumab
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Oct 2022to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: ES SCLC patients treated with first line chemo-immunotherapy (EP-IO
Who may be able to join
- histologically- or cytologically-documented extensive-stage SCLC
- to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors
- No evidence of brain metastases at diagnosis
- ECOG PS 0-2
- adult patients (aged ≥ 18 years) at diagnosis;
- signing of informed consent approved by the local Ethic Committee
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Rome, 00168
Emilio Bria, Professor, 0630155202 ext. +39, emilio.bria@policlinicogemelli.it
About this study
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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Atezolizumab
- Keywords
- sclc, immunotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Upfront chemo-immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| ES-SCLC | ES-SCLC receiving upfront chemo-immunotherapy Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Measured: Up to 60 months
OS
Time from treatment start to the date of death from any cause, assessed up to 60 months
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start4 Oct 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bria Emilio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797493
- Sponsor's protocol ID
- 5061
- Acronym
- PICASSO
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05797493
- Acronym / sponsor ID
- PICASSO / 5061
- Conditions
- Small Cell Lung Cancer
- Keywords
- sclc, immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ES-SCLC | – | Drug: AtezolizumabES-SCLC receiving upfront chemo-immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ES SCLC patients treated with first line chemo-immunotherapy (EP-IO
Key inclusion criteria (6 listed)
- histologically- or cytologically-documented extensive-stage SCLC
- to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors
- No evidence of brain metastases at diagnosis
- ECOG PS 0-2
- adult patients (aged ≥ 18 years) at diagnosis;
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| AtezolizumabUpfront chemo-immunotherapy | Drug | ES-SCLC |
Primary outcome
PFS
Time frame: Up to 60 months
Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
OS
Time frame: Up to 60 months
Time from treatment start to the date of death from any cause, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilio Bria, Prof. (+39 0630156318, emilio.bria@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 60 months). The study lists 2 primary outcomes in all. 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 4 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.