Category: Study Design
Labels: rationale, framework
Creation date and Author: Onboarding, December 17th 2024
Last Update and Author: Astrid C., October 24th 2025
Related questions:
- What is the Rosalind Study?
- What is the goal of the Rosalind study?
Introduction
Cure51 has been established as a private French TechBio company, co-founded by leading European cancer centers: Gustave Roussy, Centre Léon Bérard, Charité, and Vall d’Hebron Institute of Oncology. World-class life science investors have also been engaged in supporting the initiative.
The Rosalind Study is a first of its kind multi-centre, retrospective and observational study to profile the biology of extraordinary cancer survivors and ultimately deliver novel therapeutics to patients. Rosalind is built on global partnerships with leading oncology centres coming together to build a best-in-class dataset around outliers in cancer survival, particularly in poor-prognosis solid tumours, leveraging multi-omics and machine learning to unpick complex biology, and uncover novel targets for drug development.
To date, ROSALIND has been recruiting in three key indications:
Metastatic pancreatic ductal adenocarcinoma (mPDAC): led by Gustave Roussy Cancer Campus
Glioblastoma IDH wild-type (GBM IDH-wt): led by Centre Léon Bérard and Vall d’Hebron Institute
Extensive small-cell lung cancer (ES-SCLC): led by Charité Comprehensive Cancer Center
Participants and Methodology
Patients are being categorized into two groups:
Case group (outliers): patient who shows a ≥5 years overall survival from stage 4 diagnosis for mPDAC, ES-SCLC and GBM IDH-wt.
Control group: a patient matched to a case (age, treatment, tumor type, and other clinical parameters), whose death was observed at the median overall survival, with a variation of ± 25%, as reported in the reference clinical trials for that specific type of cancer.
The study is being conducted retrospectively using archived clinical data and biological samples (e.g., biopsies, surgical specimens). No experimental treatments are being administered. Instead, tumor samples are being analyzed using multi-omics technologies, including:
Whole-exome sequencing
Transcriptomics
Proteomics
Tumor microbiome profiling
Spatial transcriptomics
Only somatic (tumor-specific) alterations are being studied. Germline (inherited) mutations are not being assessed.
Primary Objective
The Primary Objective of the study is to identify and describe a comprehensive biological signature (digital histology, radiomics, genomics (somatic mutations), transcriptomics (somatic mutations), proteomics, epigenomics, and clinical signature) associated with patients who have exceptional survival (cases) compared to patients with standard survival (controls).
The primary endpoint is case/control status.
Secondary objectives
Explore and identify global signatures across the entire population of the three cohorts.
Describe the clinical, digital pathology, radiomic, somatic genomic, transcriptomic, proteomic, and epigenomic signatures associated with patients with unexpected survival for each cohort and across all cohorts (pan-cohort).
Tertiary/exploratory objectives
Compare, in the three patient cohorts, long-term survivors (cases) and the control group in terms of:
- Somatic genetic alterations, gene expression, and identified fusion genes.
- Methylation levels.
- Cell landscape and its interactions, using molecular imaging and single-cell profiling.
- Intratumoral microbiome and microbiome composition.
- Metabolomic pathways.
Study Design and Timeline
The ROSALIND study is a purely retrospective, observational study of secondary use of clinical data without human intervention.
Sample Size: 170 case and 170 control patients per cohort are being targeted.
Screening Requirement: Due to an estimated 50% attrition rate, a larger pool is being examined.
Inclusion Period: 24 months
Overall Duration: +54 months, including sequencing, analysis, and ongoing research consultations.
Scientific activities may continue beyond this period, until mutual written agreement is reached for termination of the project.
Participating Centers
The study is being coordinated by Cure51 in partnership with the following leading institutions:
Institut Gustave Roussy Institute (Paris, France)
Centre Léon Bérard (Lyon, France)
Charité (Berlin, Germany)
Vall d'Hebron Institute of Oncology (Barcelona, Spain)
To date (July 2025), collaboration has been established with over 200 oncology centers globally.