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Completed

NCT Number: NCT03546127

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: an average of 6 weeks

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

Secondary outcomes

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

    Time frame: Throughout the study period, on average of 3 months

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

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

    Time frame: an average of 8 weeks

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

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

    Time frame: Throughout the study period, on average of 3 months

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

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

    Time frame: on average of 2 weeks

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

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

    Time frame: Throughout the study period, on average of 3 months

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

  6. Delay time to receipt nucleic acids on CNRGH from samples receipt on platform

    Time frame: on average of 1 week

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

  7. The rate of patients with samples sending date completed on electronic case for whom samples have been received by platform

    Time frame: Throughout the study period, on average of 3 months

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

  8. 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

    Time frame: Throughout the study period, on average of 3 months

    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

  9. 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

    Time frame: Throughout the study period, on average of 3 months

    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

  10. 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

    Time frame: Throughout the study period, on average of 3 months

    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

  11. Delay time to receive all sequencing files from nucleic acids receipt on CNRGH

    Time frame: on average of 3 weeks

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

  12. The rate of patients with nucleic acids received on CNRGH for whom all sequencing files have been qualified by bioinformatics platform

    Time frame: Throughout the study period, on average of 3 months

    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

  13. The rate of patients with nucleic acids received on CNRGH for whom sequencing have been qualified by CNRGH

    Time frame: Throughout the study period, on average of 3 months

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

  14. Delay time to receive bioinformatics analysis for interpretation from availability of all sequencing files

    Time frame: on average of 1 week

    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

  15. The rate of patients with sequencing files received by bioinformatic Platform for whom these files have been qualified for analysis

    Time frame: Throughout the study period, on average of 3 months

    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

  16. The rate of patients with sequencing files received by bioinformatic Platform for whom analysis have been transmitted for interpretation

    Time frame: Throughout the study period, on average of 3 months

    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

  17. Delay time to send a validated exome sequencing report from availability of bioinformatic analysis

    Time frame: on average of 1 week

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

  18. The rate of patients with bioinformatic analysis available for interpretation for whom biological interpretation has been performed

    Time frame: Throughout the study period, on average of 3 months

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

  19. The rate of patients with bioinformatic analysis available for interpretation for whom results has been discussed by MTB

    Time frame: Throughout the study period, on average of 3 months

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

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • CNRGH, Evry
  • EUCLID Clinical Trial Platform
  • Institut Bergonié
  • Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris
  • Plateforme labellisée Inca - Institut Bergonié, Bordeaux

Registry information

Official study title

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

Acronym: MULTIPLI-0

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2018
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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