Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Sarcoma

Colorectal Neoplasms

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Soft Tissue Sarcoma

Patients with advanced/metastatic soft-tissue sarcoma

Patients with metastatic colorectal carcinoma

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.

Next Generation Sequencing (NGS): exome, RNA seq

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

The first France disease genomic medicine program in the field of cancer has been retained by the 2025 Genomic Medicine France Plan. This program, called MULTIPLI encompasses two innovative personalized medicine clinical trials in soft-tissue sarcoma and colorectal carcinoma involving targeted molecules according to the tumor profile of each patient.

This 1st clinical research program aims implementing exome sequencing and RNA sequencing to determine the genomic profile and to provide a therapeutic decision for each patient. Genomic analyzes will be performed on different technical platforms: samples will be collected in each investigating center, nucleic acids extraction will be performed on two genetic platforms, Inca labeled and identified for the purpose of this study: Institut Bergonié and Hôpital Européen Georges Pompidou. CNRGH (Centre National de Recherche en Génomique Humaine) was retained for operational platform genomics and Institut Bergonie for bioinformatics data processing. Each genomic profile will be discussed within a multidisciplinary tumor board which aims at providing a therapeutic decision for each patient and to propose a targeted treatment in case of actionable molecular alteration.

The purpose of this program is to perform analysis on a set of gene, in order to provide results no more than after 6 weeks after the sample arrival on the biopathological platform. This gene panel analysis is based on the predefined list of genes that are direct targets of the drugs available in the MULTIPLI program.

Before implanting this program in a large-scale launch, it was essential to set up a pilot study in order to evaluate both sample's management between several platforms, and the time to report the results, and to verify that it was in line with the objectives set.

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)

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

Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)

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

Rate of patients for whom a report was transmitted, within the patients for whom the samples were received by the platforms

The time delay between the date of informed consent signature and the date of dispatch of a validated MTB report to physician

Rate of patients for whom a report was transmitted, within the patients for whom signed consent has been signed

The time delay between the date of informed consent signature and the date of sample receipt on platform

Rate of patients for whom samples have been received by platform, within the patients for whom signed consent has been signed

The time delay between the date of sample receipt on platform and the date of nucleic acids receipt on CNRGH

Rate of patients for whom samples have been received by platform, within the patients for whom sending date has been completed on electronic case

Rate of patients for whom samples have been qualified in first step by platform and nucleic acids received by CNRGH, within the patients for whom samples have been received by platform

Rate of patients for whom samples have been qualified in second step by platform and nucleic acids received by CNRGH, within the patients for whom samples have been received by platform

Rate of patients for whom samples have been qualified in first and second step by platform and nucleic acids received by CNRGH, within the patients for whom samples have been received by platform

The time delay between the date of nucleic acids receipt on CNRGH and the date of receipt of all sequencing files by bioinformatic platform

Rate of patients for whom all sequencing files have been qualified by bioinformatics platform, within the patients for whom samples have been received by CNRGH

Rate of patients for whom sequencing have been qualified by CNRGH, within the patients for whom samples have been received by CNRGH

The time delay between the date of receipt of all sequencing files by bioinformatics platform and the date of receipt of bioinformatics analysis by biologist for interpretation

Rate of patients for whom all sequencing file have been qualified by bioinformatic platform, within the patients for whom all sequencing file have been received by bioinformatic platform

Rate of patients for whom bioinformatic analysis have been transmitted for interpretation, within the patients for whom all sequencing file have been received by bioinformatic platform

The time delay between the date of bioinformatic analysis availability for interpretation and the date of dispatch of a validated MTB report to physician

Rate of patients for whom bioinformatic analysis has been interpreted by biologist, within the patients for whom bioinformatics analysis have been transmitted

Rate of patients for whom biological report has been discussed by MTB, within the patients for whom bioinformatics analysis have been transmitted

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study	NCT03546127	Colorectal Carc... Soft Tissue Sar...	Next Generation...	18 Years -	Institut National de la Santé Et de la Recherche Médicale, France
Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study	NCT03546127	Colorectal Carc... Soft Tissue Sar...	Next Generation...	18 Years -	Institut National de la Santé Et de la Recherche Médicale, France

Spots Global Cancer Trial Database for next generation sequencing (ngs): exome, rna seq