RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer (RASANC)

November 16, 2016 updated by: Association des Gastroentérologues Oncologues

RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer: Concordance With the "Standard" Testing Method From Tumor Tissue and Review of Associated Timelines and Costs

This study will evaluate the concordance of RAS mutation detection between the results obtained from circulating tumor DNA and those obtained with the "standard" method (testing from tumor tissue).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bobigny, France
        • Recruiting
        • Hopital Avicenne
        • Contact:
          • Thomas Aparicio, Pr
      • Clamart, France
        • Recruiting
        • Hôpital Béclère
        • Contact:
          • L Marthey, Dr
      • Creteil, France
        • Recruiting
        • Hopital Henri Mondor
        • Contact:
          • Christophe Tournigand, Pr
      • Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Kremlin-Bicêtre
        • Contact:
          • Anne Thirot- Bidault, Dr
      • Longjumeau, France
        • Recruiting
        • CH Longjumeau et Sud
        • Contact:
          • J Ezenfis, Dr
      • Lyon, France
        • Recruiting
        • Hopital Mermoz
        • Contact:
          • Gérard Lledo, Dr
      • Paris, France
        • Recruiting
        • Hôpital Saint-Antoine
        • Contact:
          • Thierry André, Pr
      • Paris, France
        • Recruiting
        • Hôpital Europeén Georges Pompidou
        • Contact:
          • Julien TAIEB, Pr
      • Paris, France
        • Recruiting
        • Hôpital Cochin
        • Contact:
          • Romain Coriat, Pr
      • Paris, France
        • Recruiting
        • Hôpital Saint-Louis
        • Contact:
          • Jean-Marc Gornet, Dr
      • Paris, France
        • Recruiting
        • Hôpital Pitie Salpétrière
        • Contact:
          • Jean-Baptiste Bachet, Dr
      • Poitiers, France
        • Recruiting
        • CHU Poitiers
        • Contact:
          • DAVID TOUGERON, PR
      • Reims, France
        • Recruiting
        • CHU Robert Debre
      • Tours, France
        • Recruiting
        • Hôpital TROUSSEAU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers

Description

Inclusion Criteria:

  • Pathologically confirmed metachronous or synchronous metastatic colorectal cancer
  • No prior chemotherapy with the exception of adjuvant chemotherapy completed ≥ 6 months prior to enrollment
  • Signed written informed consent obtained prior to any study specific screening procedures
  • Patients willing to provide a blood sample for Translational Research

Exclusion Criteria:

  • No tumor block available
  • Previous malignancy in the last 5 years
  • Medical, sociological, psychological or legal conditions that would not permit the patient to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods
Time Frame: Baseline
RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods in patients for whom circulating tumor DNA has been identified in the avalaible plasma sample.
Time Frame: Baseline
RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA. This subgroup of patients is defined as patients with at least one mutation identified in the panel of tested genes (Ion AmpliSeq Colon and Lung Cancer Panel) (RAS mutation or mutations on other genes TP53, PIK3CA, SMAD4 .... ) or with at least one methylated biomarker identified (for patients with no mutation identified in the panel of genes tested).
Baseline
Comparison of the timelines to obtain results between the two methods
Time Frame: Baseline
Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA
Baseline
Comparisons of the costs between the two methods
Time Frame: Baseline
Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Association des Gastroentérologues Oncologues

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Baptiste Bachet, Dr, Association des Gastro-entérologues Oncologues (AGEO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RASANC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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