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

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ClinicalTrials.gov Identifier: NCT02502656
Recruitment Status : Unknown
Verified November 2016 by Association des Gastroentérologues Oncologues.
Recruitment status was:  Recruiting
First Posted : July 20, 2015
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Association des Gastroentérologues Oncologues

Brief Summary:
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).

Condition or disease
Colorectal Cancer

Study Type : Observational
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : July 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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


Biospecimen Retention:   Samples With DNA
Blood collection will be performed on the day of the first oncological consultation


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502656


Contacts
Contact: Jean-Baptiste Bachet, Dr jean-baptiste.bachet@psl.aphp.fr

Locations
France
Hôpital Avicenne Recruiting
Bobigny, France
Contact: Thomas Aparicio, Pr         
Hopital Béclère Recruiting
Clamart, France
Contact: L Marthey, Dr         
Hopital Henri Mondor Recruiting
Creteil, France
Contact: Christophe Tournigand, Pr         
Hopital Kremlin-Bicêtre Recruiting
Kremlin-Bicêtre, France
Contact: Anne Thirot- Bidault, Dr         
CH Longjumeau et Sud Recruiting
Longjumeau, France
Contact: J Ezenfis, Dr         
Hopital Mermoz Recruiting
Lyon, France
Contact: Gérard Lledo, Dr         
Hopital Cochin Recruiting
Paris, France
Contact: Romain Coriat, Pr         
Hopital Saint-Antoine Recruiting
Paris, France
Contact: Thierry André, Pr         
Hopital Saint-Louis Recruiting
Paris, France
Contact: Jean-Marc Gornet, Dr         
Hôpital Européen Georges Pompidou Recruiting
Paris, France
Contact: Julien Taieb, Pr         
Hôpital Pitié Salpêtrière Recruiting
Paris, France
Contact: Jean-Baptiste Bachet, Dr         
CHU Poitiers Recruiting
Poitiers, France
Contact: David Tougeron, Pr         
CHU Robert Debré Recruiting
Reims, France
Contact: Olivier Bouché, Pr         
Hôpital Trousseau Recruiting
Tours, France
Contact: Thierry Lecomte, Pr         
Sponsors and Collaborators
Association des Gastroentérologues Oncologues
Investigators
Principal Investigator: Jean-Baptiste Bachet, Dr Association des Gastro-entérologues Oncologues (AGEO)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Association des Gastroentérologues Oncologues
ClinicalTrials.gov Identifier: NCT02502656     History of Changes
Other Study ID Numbers: RASANC
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by Association des Gastroentérologues Oncologues:
RAS mutation
DNA
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases