Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study

NCT03546127 | Completed

• 1 other identifier: C17-11 MULTIPLI
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.

Conditions

Colorectal Carcinoma; Soft Tissue Sarcoma

Keywords

Next Generation Sequencing; Exome; RNA sequencing; Soft-tissue sarcoma; Colorectal carcinoma

Outcome Measures

Primary Outcomes (1)

• Delay time to send a validated exome sequencing report from sample receipt

  The time delay between the date of sample receipt by the platform and the date of dispatch of a validated MTB report to physician

  an average of 6 weeks

Secondary Outcomes (19)

• The rate of patients with samples received by Platform for whom a validated exome sequencing report is available

  Throughout the study period, on average of 3 months

• Delay time to send a validated exome sequencing report from signature to informed consent by the patient

  an average of 8 weeks

• The rate of patients with signed informed consent for whom a validated exome sequencing report is available

  Throughout the study period, on average of 3 months

• Delay time to receive sample on Platform from signature of informed consent

  on average of 2 weeks

• The rate of patients with signed informed consent for whom samples have been received by platform

  Throughout the study period, on average of 3 months

Study Arms (2)

STS

Patients with advanced/metastatic soft-tissue sarcoma

Genetic: Next Generation Sequencing (NGS): exome, RNA seq

CCR

Patients with metastatic colorectal carcinoma

Genetic: Next Generation Sequencing (NGS): exome, RNA seq

Interventions

Next Generation Sequencing (NGS): exome, RNA seq GENETIC

Tumor and blood samples will be sequenced at medium-high coverage at the whole genome (exome) and transcriptome levels (RNA Seq). This will allow detecting variants in a larger set of samples even though only from the main clone will be precisely measured. The whole exome will be performed at a mean coverage of at least 60x for the normal DNA samples and 120x for the tumor DNA samples. The transcriptome of the tumor will be performed at enough depth of coverage to detect gene fusions, transcriptome variants and measure the digital expression of already annotated isoforms. For both sequencing configurations: * Data from each cancer and normal genome will be analysed for the presence of somatic variants. * DNA and RNA sequencing results will be integrated. * Technical replication for the mutations / chromosome alterations / transcript fusions that most likely drive the tumour process will be performed via Target Resequencing of the genomic / coding regions of interest.

CCR; STS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in this prospective cohort study are patients who have previously consented to tumor sequencing either as part of others studies or as part of standard care (voluntary signed informed consent). Two participating centers have been retained. Samples used (blood and tumor) are issued from these previous collection and analyzed for the same purpose: no additional samples will be collected.

You may qualify if:

• Adult patients
• Disease: Advanced and/or metastatic soft-tissue sarcoma OR metastatic carcinoma
• Patient consenting to tumor sequencing, secondary reuse of their data
• Patient informed about this study

You may not qualify if:

• N/A

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Institut Bergonié: collaborator
• Plateforme labellisée Inca - Institut Bergonié, Bordeaux: collaborator
• Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris: collaborator
• CNRGH, Evry: collaborator
• EUCLID Clinical Trial Platform: collaborator

Study Sites (3)

Institut Bergonié

Bordeaux, 33076, France

Location

CEA / Centre National de Recherche en Génomique Humaine

Évry, 91057, France

Location

Hôpital Européen Georges Pompidou

Paris, 75000, France

Location

Related Publications (1)

• FGM 2025 Workflow Study Group (Alliance nationale des Sciences de la Vie et de la Sante); Auzanneau C, Bacq D, Bellera C, Blons H, Boland A, Boucheix M, Bourdon A, Chollet E, Chomienne C, Deleuze JF, Delmas C, Dinart D, Esperou H, Geillon F, Geneste D, Italiano A, Jean D, Khalifa E, Laizet Y, Laurent-Puig P, Lethimonnier F, Levy-Marchal C, Lucchesi C, Malle C, Mancini P, Mathoulin-Pelissier S, Meyer V, Marie-Ange P, Perkins G, Sellan-Albert S, Soubeyran I, Wallet C. Feasibility of high-throughput sequencing in clinical routine cancer care: lessons from the cancer pilot project of the France Genomic Medicine 2025 plan. ESMO Open. 2020 Jul;5(4):e000744. doi: 10.1136/esmoopen-2020-000744.

  PMID: 32713836 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

For each participant, biological specimens will be collected for molecular analysis : * Whole blood sample for constitutional characteristics * Tumor sample (fresh-frozen or formalin-fixed paraffin embedded)

MeSH Terms

Conditions

Colorectal Neoplasms; Sarcoma

Interventions

High-Throughput Nucleotide Sequencing; Base Sequence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 6, 2018
• Study Start: May 23, 2017
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)