Colorectal CarcinomaMULTIPLI-0NCT03546127
Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study
An observational study of Colorectal Carcinoma and Soft Tissue Sarcoma, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
Trial summary
Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Soft Tissue Sarcoma
- What is being tested?
- Next Generation Sequencing (NGS): exome, RNA seq
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 23 May 2017to 21 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Bergonié
Bordeaux, 33076
CEA / Centre National de Recherche en Génomique Humaine
Évry, 91057
Hôpital Européen Georges Pompidou
Paris, 75000
About this study
Official title: Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)
Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.
Read the 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.
- Conditions
- Colorectal Carcinoma, Soft Tissue Sarcoma
- Being tested
- Next Generation Sequencing (NGS): exome, RNA seq
- Keywords
- Next Generation Sequencing, Exome, RNA sequencing, Soft-tissue sarcoma, Colorectal carcinoma
- Medical subject headings
- Colorectal Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Sequencing (NGS): exome, RNA seqGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| STS | Patients with advanced/metastatic soft-tissue sarcoma Receives: Genetic: Next Generation Sequencing (NGS): exome, RNA seq | |
| CCR | Patients with metastatic colorectal carcinoma Receives: Genetic: Next Generation Sequencing (NGS): exome, RNA seq |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Rate of patients for whom a report was transmitted, within the patients for whom the samples were received by the platforms
Measured: 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
The time delay between the date of informed consent signature and the date of dispatch of a validated MTB report to physician
Measured: an average of 8 weeks
The rate of patients with signed informed consent for whom a validated exome sequencing report is available
Rate of patients for whom a report was transmitted, within the patients for whom signed consent has been signed
Measured: Throughout the study period, on average of 3 months
Delay time to receive sample on Platform from signature of informed consent
The time delay between the date of informed consent signature and the date of sample receipt on platform
Measured: on average of 2 weeks
The rate of patients with signed informed consent for whom samples have been received by platform
Rate of patients for whom samples have been received by platform, within the patients for whom signed consent has been signed
Measured: Throughout the study period, on average of 3 months
Delay time to receipt nucleic acids on CNRGH from samples receipt on platform
The time delay between the date of sample receipt on platform and the date of nucleic acids receipt on CNRGH
Measured: on average of 1 week
The rate of patients with samples sending date completed on electronic case for whom samples have been received by platform
Rate of patients for whom samples have been received by platform, within the patients for whom sending date has been completed on electronic case
Measured: Throughout the study period, on average of 3 months
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
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
Measured: Throughout the study period, on average of 3 months
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
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
Measured: Throughout the study period, on average of 3 months
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
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
Measured: Throughout the study period, on average of 3 months
Delay time to receive all sequencing files from nucleic acids receipt on CNRGH
The time delay between the date of nucleic acids receipt on CNRGH and the date of receipt of all sequencing files by bioinformatic platform
Measured: on average of 3 weeks
The rate of patients with nucleic acids received on CNRGH for whom all sequencing files have been qualified by bioinformatics 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
Measured: Throughout the study period, on average of 3 months
The rate of patients with nucleic acids received on CNRGH for whom sequencing have been qualified by CNRGH
Rate of patients for whom sequencing have been qualified by CNRGH, within the patients for whom samples have been received by CNRGH
Measured: Throughout the study period, on average of 3 months
Delay time to receive bioinformatics analysis for interpretation from availability of all sequencing files
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
Measured: on average of 1 week
The rate of patients with sequencing files received by bioinformatic Platform for whom these files have been qualified for analysis
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
Measured: Throughout the study period, on average of 3 months
The rate of patients with sequencing files received by bioinformatic Platform for whom analysis have been transmitted for interpretation
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
Measured: Throughout the study period, on average of 3 months
Delay time to send a validated exome sequencing report from availability of bioinformatic analysis
The time delay between the date of bioinformatic analysis availability for interpretation and the date of dispatch of a validated MTB report to physician
Measured: on average of 1 week
The rate of patients with bioinformatic analysis available for interpretation for whom biological interpretation has been performed
Rate of patients for whom bioinformatic analysis has been interpreted by biologist, within the patients for whom bioinformatics analysis have been transmitted
Measured: Throughout the study period, on average of 3 months
The rate of patients with bioinformatic analysis available for interpretation for whom results has been discussed by MTB
Rate of patients for whom biological report has been discussed by MTB, within the patients for whom bioinformatics analysis have been transmitted
Measured: Throughout the study period, on average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start23 May 2017
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Institut Bergonié, Plateforme labellisée Inca - Institut Bergonié, Bordeaux, Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris, CNRGH, Evry, EUCLID Clinical Trial Platform
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546127
- Sponsor's protocol ID
- C17-11 MULTIPLI
- Acronym
- MULTIPLI-0
- Status last verified
- Sep 2025
- First submitted
- 17 May 2018
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32713836
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study (MULTIPLI-0)
- ClinicalTrials.gov ID
- NCT03546127
- Acronym / sponsor ID
- MULTIPLI-0 / C17-11 MULTIPLI
- Conditions
- Colorectal Carcinoma, Soft Tissue Sarcoma
- Keywords
- Next Generation Sequencing, Exome, RNA sequencing, Soft-tissue sarcoma, Colorectal carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Institut Bergonié, Plateforme labellisée Inca - Institut Bergonié, Bordeaux, Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris, CNRGH, Evry, EUCLID Clinical Trial Platform
- Study start
- 23 May 2017 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STS | – | Genetic: Next Generation Sequencing (NGS): exome, RNA seqPatients with advanced/metastatic soft-tissue sarcoma |
| CCR | – | Genetic: Next Generation Sequencing (NGS): exome, RNA seqPatients with metastatic colorectal carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Generation Sequencing (NGS): exome, RNA seqTumor 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. | Genetic | CCR, STS |
Primary outcome
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
19 secondary outcomes
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
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 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
Delay time to receive sample on Platform from signature of informed consent
Time frame: on average of 2 weeks
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
Delay time to receipt nucleic acids on CNRGH from samples receipt on platform
Time frame: on average of 1 week
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
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
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
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
Delay time to receive all sequencing files from nucleic acids receipt on CNRGH
Time frame: on average of 3 weeks
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
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
Delay time to receive bioinformatics analysis for interpretation from availability of all sequencing files
Time frame: on average of 1 week
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
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
Delay time to send a validated exome sequencing report from availability of bioinformatic analysis
Time frame: on average of 1 week
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 32713836FGM 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma and Soft Tissue Sarcoma, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay time to send a validated exome sequencing report from sample receipt (time frame: an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.