- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06160596
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis (ROSALIND)
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:
- 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wolikow Nicolas, Master
- Phone Number: 0033772042022
- Email: nicolas@cure51.com
Study Contact Backup
- Name: Simon Istolainen, Master
- Phone Number: 0033626955716
- Email: simon@cure51.com
Study Locations
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-
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Villejuif, France, 94805
- Recruiting
- Gustave Roussy Cancer Campus, Grand Paris
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Contact:
- Julieta Rodriguez, MD
- Phone Number: 0033644803131
- Email: Julieta.RODRIGUEZ@gustaveroussy.fr
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Contact:
- Christophe Javaud
- Phone Number: 0033607234157
- Email: Christophe.JAVAUD@gustaveroussy.fr
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Principal Investigator:
- Julieta Rodriguez, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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:
- 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).
Exclusion Criteria for both groups :
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
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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).
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|
GLIOBLASTOMA SURVIVORS & CONTROLS
Glioblastoma (GBM) (IDH mutated excluded)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EXCEPTIONAL SURVIVAL
Time Frame: 54 months
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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. |
54 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julieta Rodriguez, MD, Gustave Roussy, Cancer Campus, Grand Paris
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Lung Neoplasms
- Glioblastoma
- Small Cell Lung Carcinoma
Other Study ID Numbers
- 2022-A02541-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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