Clinical trial NCT03546127: Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study
Official title: Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Carcinoma
Soft Tissue Sarcoma
Keywords: Next Generation Sequencing
Exome
RNA sequencing
Soft-tissue sarcoma
Colorectal carcinoma
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Institut Bergonié
name: Plateforme labellisée Inca - Institut Bergonié, Bordeaux
name: Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris
name: CNRGH, Evry
name: EUCLID Clinical Trial Platform
First posted: 2018-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Delay time to send a validated exome sequencing report from sample receipt
timeFrame: an average of 6 weeks
Secondary outcomes:
measure: The rate of patients with samples received by Platform for whom a validated exome sequencing report is available
timeFrame: Throughout the study period, on average of 3 months
measure: Delay time to send a validated exome sequencing report from signature to informed consent by the patient
timeFrame: an average of 8 weeks
measure: The rate of patients with signed informed consent for whom a validated exome sequencing report is available
timeFrame: Throughout the study period, on average of 3 months
measure: Delay time to receive sample on Platform from signature of informed consent
timeFrame: on average of 2 weeks
measure: The rate of patients with signed informed consent for whom samples have been received by platform
timeFrame: Throughout the study period, on average of 3 months
measure: Delay time to receipt nucleic acids on CNRGH from samples receipt on platform
timeFrame: on average of 1 week
measure: The rate of patients with samples sending date completed on electronic case for whom samples have been received by platform
timeFrame: Throughout the study period, on average of 3 months
measure: The rate of patients with samples received on platform for whom these samples have been qualified in first step by platform and nucleic acids have been received by CNRGH
timeFrame: Throughout the study period, on average of 3 months
measure: The rate of patients with samples received on Platform for whom these samples have been qualified in second step by platform and nucleic acids have been received by CNRGH
timeFrame: Throughout the study period, on average of 3 months
measure: The rate of patients with samples received on platform for whom these samples have been qualified in first and second step by Platform and nucleic acids have been received by CNRGH
timeFrame: Throughout the study period, on average of 3 months
measure: Delay time to receive all sequencing files from nucleic acids receipt on CNRGH
timeFrame: on average of 3 weeks
measure: The rate of patients with nucleic acids received on CNRGH for whom all sequencing files have been qualified by bioinformatics platform
timeFrame: Throughout the study period, on average of 3 months
measure: The rate of patients with nucleic acids received on CNRGH for whom sequencing have been qualified by CNRGH
timeFrame: Throughout the study period, on average of 3 months
measure: Delay time to receive bioinformatics analysis for interpretation from availability of all sequencing files
timeFrame: on average of 1 week
measure: The rate of patients with sequencing files received by bioinformatic Platform for whom these files have been qualified for analysis
timeFrame: Throughout the study period, on average of 3 months
measure: The rate of patients with sequencing files received by bioinformatic Platform for whom analysis have been transmitted for interpretation
timeFrame: Throughout the study period, on average of 3 months
measure: Delay time to send a validated exome sequencing report from availability of bioinformatic analysis
timeFrame: on average of 1 week
measure: The rate of patients with bioinformatic analysis available for interpretation for whom biological interpretation has been performed
timeFrame: Throughout the study period, on average of 3 months
measure: The rate of patients with bioinformatic analysis available for interpretation for whom results has been discussed by MTB
timeFrame: Throughout the study period, on average of 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Évry
country: France
facility: CEA / Centre National de Recherche en Génomique Humaine
Study officials:
References: