Pancreas AdenocarcinomaROSALINDNCT06160596
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
An observational study of Pancreas Adenocarcinoma and Small-cell Lung Cancer, run by Cure 51 at 1 site in France.
Trial summary
This is a retrospective, exploratory, multi-center, translational, 3 cohorts case control matched study conducted in patients harboring a solid tumor with poor prognosis who presented a long-term (case) and standard (standard) survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma, Small-cell Lung Cancer, Glioblastoma, IDH-wildtype
- What is being tested?
- Long term survival multimodal analysis
- How many people
- 1,020 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 1 May 2028
- 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: Primary and secondary care clinic, oncology centers
Who may be able to join
- FOR SURVIVORS
- To be eligible the exceptional survivor patients must fulfill the following inclusion criteria:
- Adult patient (≥18 years old at diagnosis).
- Three distinct cohorts, one of patients harbouring metastatic pancreatic ductal adenocarcinoma, glioblastoma IDHwt, extensive small cell lung cancer.
- Long-term survival is defined as an exceptionally long survival ≥ 5 years from stage IV diagnosis for PDAC, extensive SCLC, and ≥ 3 years for GBM-IDHwt.
- Availability of at least one block sample and associated clinical annotations with following characteristics:
Show all 18Show fewer
- One block sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses, according to requirements specified in Lab manual
- Any treatment prior to sample acquisition must be reported - all treatments accepted (standard / targeted);
- Samples should be at least 5 years old for PDAC and SCLC and 3 years old for GBM
- For CONTROL GROUPS :
- To be eligible the control patients must fulfill the following inclusion criteria:
- ≥18 years old at diagnosis.
- Three distinct cohorts, one of patients suffering from metastatic pancreatic ductal adenocarcinoma, one for glioblastoma, one for extensive small cell lung cancer.
- Paired to long-term survivors as mentioned in the methodology section
- Death or median overall survival with a variation of 10% before of beyond as reported in pivotal clinical trials in the specific type disease
- Availability of at least one tumor sample and associated clinical annotations with following characteristics:
- Sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses
- Any treatment prior to sample acquisition must be reported (treatment-naive samples should be preferred) - all treatments accepted (standard / targeted).
Who cannot join
- Patient must not be enrolled if he/she fulfils one of the following non-inclusion criteria:
- <18 years old at diagnosis.
- Hematological malignancy or solid tumors, which are not in the scope of tumor types, described in the inclusion criteria.
- Tumor sample not available or not reaching the required quality for multi-omic analyses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus, Grand Paris
Villejuif, 94805
Julieta Rodriguez, MD, 0033644803131, Julieta.RODRIGUEZ@gustaveroussy.fr
Christophe Javaud, 0033607234157, Christophe.JAVAUD@gustaveroussy.fr
About this study
Official title: Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study
This is a retrospective, exploratory, multi-center, translational, 3 cohorts case control matched study conducted in patients harboring a solid tumor with poor prognosis who presented a long-term (case) and standard (standard) survival.
Patients with:
Read more
- Cohort A: metastatic pancreatic ductal adenocarcinoma
- Cohort B: glioblastoma IDHwt
- Cohort C: extensive small cell lung cancer
This research aims to integrate data generated from clinical records, imaging, multi-omics and bioinformatics approaches to discriminate case and control and then to identify new therapeutic targets. Analyses will be performed depending on the tumor samples available with at least 3 omics levels and according to scientific advances; genomic, epigenomic, proteomics, metabolomics, transcriptomic, microbiomic.
Read the detailed description
We propose for the first time to build a large collection of samples from unexpected survivors and controls with standard survival to identify biomarkers of resistance and/or survival which would help developing new cancer therapeutics. Biological samples and clinical records will be collected and then centralised to extract the data of any patients who have survived more than 5 years for the cohorts of PDAC and SCLC and more than 3 years for the cohort of GMB-IDHwt from the day of diagnosis. In addition to the clinical record of the patient describing his/her history (including multiscale imaging, pathology, biological sample analysis), we will collect every point of data possible with current technologies, such as multi-omics including genome, proteome, transcriptome, epigenomic, metabolome and microbiome. The data set of these multi-omic groups are combined and are complementary to identify a certain biological function and its cellular source. Such complementary effects and synergistic interactions between omic layers in the life course can only be captured by integrative study of multiple molecular layers. Artificial intelligence (AI), specifically machine learning algorithms, will also help to understand these multi-omics data. AI can also bring a new layer of biomarker discovery enabling the analysis of whole slide images of biopsies with computer vision and linking those biomarkers to the multi omics genomic features. After interpreting the comprehensive data with our set-up bioinformatics team in coordination with the various centres, we expect to find molecular signatures and consequently therapeutic approaches to address patients and physicians unmet needs.
- Being tested
- Long term survival multimodal analysis
- Medical subject headings
- Small Cell Lung Carcinoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term survival multimodal analysisGenetic
- To describe global signatures (Digital histology, Radiomic, Genomic, Transcriptomic, Proteomic, (Epigenomic) and clinical signature) that are associated with a patient's unexpected survival compared to standard patients across three cohorts of solid tumors with unmet medical needs.
- To describe global signatures in the overall population (pan-cohort).
- To describe clinical, digital pathology, radiomic, genomic, transcriptomic, proteomic and epigenomic signatures associated with patients' unexpected survival compared to standard patients for each cohort and in all cohorts (pan-cohort)
| Study group | Role | What they receive |
|---|---|---|
| PDAC STAGE IV SURVIVORS & CONTROLS | Metastatic pancreatic ductal adenocarcinoma (PDAC) (Other histologies such as adenosquamous carcinoma, hepatoid carcinoma, anaplastic undifferentiated carcinoma and medullary carcinoma, acinar cell carcinoma, neuroendocrine tumors, Solid pseudopapillary neoplasm, Pancreatoblastoma, Serous cystadenocarcinoma are excluded) Receives: Genetic: Long term survival multimodal analysis | |
| SMALL CELL LUNG CANCER EXTENSIVE STAGE SURVIVORS & CONTROLS | Extensive small cell lung cancer (SCLC) (Other histologies excluded: combined SCLC with some areas of non-small cell lung cancer (NSCLC), carcinoid tumors, typical and atypical, large cell neuroendocrine carcinoma of the lung). Receives: Genetic: Long term survival multimodal analysis | |
| GLIOBLASTOMA SURVIVORS & CONTROLS | Glioblastoma (GBM) (IDH mutated excluded) Receives: Genetic: Long term survival multimodal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
EXCEPTIONAL SURVIVAL
In this study, the primary endpoint is the long survivorship status (Y/N). Prior to locking the database, a data review meeting will be planned to review individual data and validate the Statistical Analysis Plan (SAP).
All the deviations from protocol definitions (if any) will be listed and defined as major or minor deviations in the SAP.
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cure 51
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris, Centre Leon Berard, Vall d'Hebron Institute of Oncology, Istituto Europeo di Oncologia, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Julieta Rodriguez, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160596
- Sponsor's protocol ID
- 2022-A02541-42
- Acronym
- ROSALIND
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: To be discussed internally and with the scientific advisory board later. All institutions providing patient data will have full access to multiomics sequencing raw data of their own patients for academic use.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study
- ClinicalTrials.gov ID
- NCT06160596
- Acronym / sponsor ID
- ROSALIND / 2022-A02541-42
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Cure 51University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris, Centre Leon Berard, Vall d'Hebron Institute of Oncology, Istituto Europeo di Oncologia, Charite University, Berlin, Germany
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Dec 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.
This is a retrospective, exploratory, multi-center, translational, 3 cohorts case control matched study conducted in patients harboring a solid tumor with poor prognosis who presented a long-term (case) and standard (standard) survival.
Patients with:
- Cohort A: metastatic pancreatic ductal adenocarcinoma
- Cohort B: glioblastoma IDHwt
- Cohort C: extensive small cell lung cancer
This research aims to integrate data generated from clinical records, imaging, multi-omics and bioinformatics approaches to discriminate case and control and then to identify new therapeutic targets. Analyses will be performed depending on the tumor samples available with at least 3 omics levels and according to scientific advances; genomic, epigenomic, proteomics, metabolomics, transcriptomic, microbiomic.
Detailed description
We propose for the first time to build a large collection of samples from unexpected survivors and controls with standard survival to identify biomarkers of resistance and/or survival which would help developing new cancer therapeutics. Biological samples and clinical records will be collected and then centralised to extract the data of any patients who have survived more than 5 years for the cohorts of PDAC and SCLC and more than 3 years for the cohort of GMB-IDHwt from the day of diagnosis. In addition to the clinical record of the patient describing his/her history (including multiscale imaging, pathology, biological sample analysis), we will collect every point of data possible with current technologies, such as multi-omics including genome, proteome, transcriptome, epigenomic, metabolome and microbiome. The data set of these multi-omic groups are combined and are complementary to identify a certain biological function and its cellular source. Such complementary effects and synergistic interactions between omic layers in the life course can only be captured by integrative study of multiple molecular layers. Artificial intelligence (AI), specifically machine learning algorithms, will also help to understand these multi-omics data. AI can also bring a new layer of biomarker discovery enabling the analysis of whole slide images of biopsies with computer vision and linking those biomarkers to the multi omics genomic features. After interpreting the comprehensive data with our set-up bioinformatics team in coordination with the various centres, we expect to find molecular signatures and consequently therapeutic approaches to address patients and physicians unmet needs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDAC STAGE IV SURVIVORS & CONTROLS | – | Genetic: Long term survival multimodal analysisMetastatic pancreatic ductal adenocarcinoma (PDAC) (Other histologies such as adenosquamous carcinoma, hepatoid carcinoma, anaplastic undifferentiated carcinoma and medullary carcinoma, acinar cell carcinoma, neuroendocrine tumors, Solid pseudopapillary neoplasm, Pancreatoblastoma, Serous cystadenocarcinoma are excluded) |
| SMALL CELL LUNG CANCER EXTENSIVE STAGE SURVIVORS & CONTROLS | – | Genetic: Long term survival multimodal analysisExtensive small cell lung cancer (SCLC) (Other histologies excluded: combined SCLC with some areas of non-small cell lung cancer (NSCLC), carcinoid tumors, typical and atypical, large cell neuroendocrine carcinoma of the lung). |
| GLIOBLASTOMA SURVIVORS & CONTROLS | – | Genetic: Long term survival multimodal analysisGlioblastoma (GBM) (IDH mutated excluded) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and secondary care clinic, oncology centers
Key inclusion criteria (18 listed)
- FOR SURVIVORS
- To be eligible the exceptional survivor patients must fulfill the following inclusion criteria:
- To be eligible the control patients must fulfill the following inclusion criteria:
Key exclusion criteria (4 listed)
- Patient must not be enrolled if he/she fulfils one of the following non-inclusion criteria:
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 |
|---|---|---|
| Long term survival multimodal analysis* To describe global signatures (Digital histology, Radiomic, Genomic, Transcriptomic, Proteomic, (Epigenomic) and clinical signature) that are associated with a patient's unexpected survival compared to standard patients across three cohorts of solid tumors with unmet medical needs. * To describe global signatures in the overall population (pan-cohort). * To describe clinical, digital pathology, radiomic, genomic, transcriptomic, proteomic and epigenomic signatures associated with patients' unexpected survival compared to standard patients for each cohort and in all cohorts (pan-cohort) | Genetic | GLIOBLASTOMA SURVIVORS & CONTROLS, PDAC STAGE IV SURVIVORS & CONTROLS, SMALL CELL LUNG CANCER EXTENSIVE STAGE SURVIVORS & CONTROLS |
Primary outcome
EXCEPTIONAL SURVIVAL
Time frame: 54 months
In this study, the primary endpoint is the long survivorship status (Y/N). Prior to locking the database, a data review meeting will be planned to review individual data and validate the Statistical Analysis Plan (SAP). All the deviations from protocol definitions (if any) will be listed and defined as major or minor deviations in the SAP.
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 7 Dec 2023.
- corporate website of sponsorLink provided by the sponsor.
- Individual participant dataSharing planned: No. To be discussed internally and with the scientific advisory board later. All institutions providing patient data will have full access to multiomics sequencing raw data of their own patients for academic use.
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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.
Julieta Rodriguez, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
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 Pancreas Adenocarcinoma and Small-cell Lung Cancer, run by Cure 51 at 1 site in France.
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 18 inclusion and 4 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 7 Dec 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 France. 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 Wolikow Nicolas, Master (0033772042022, nicolas@cure51.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EXCEPTIONAL SURVIVAL (time frame: 54 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 7 Dec 2023.