Clinical trial NCT02502656: RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: RAS mutation
DNA
Colorectal Cancer
Lead sponsor: Association des Gastroentérologues Oncologues
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 425
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: All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers

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).


Eligibility 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

Primary outcomes:
measure: Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods
timeFrame: Baseline
Secondary outcomes:
measure: 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.
timeFrame: Baseline
measure: Comparison of the timelines to obtain results between the two methods
timeFrame: Baseline
measure: Comparisons of the costs between the two methods
timeFrame: Baseline
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Clamart
country: France
facility: Hopital Béclère
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Kremlin-Bicêtre
country: France
facility: Hopital Kremlin-Bicêtre
city: Longjumeau
country: France
facility: CH Longjumeau et Sud
city: Lyon
country: France
facility: Hopital Mermoz
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Robert Debré
city: Tours
country: France
facility: Hôpital Trousseau
Study officials:
affiliation: Association des Gastro-entérologues Oncologues (AGEO)
name: Jean-Baptiste Bachet, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachet JB, Bouche O, Taieb J, Dubreuil O, Garcia ML, Meurisse A, Normand C, Gornet JM, Artru P, Louafi S, Bonnetain F, Thirot-Bidault A, Baumgaertner I, Coriat R, Tougeron D, Lecomte T, Mary F, Aparicio T, Marthey L, Taly V, Blons H, Vernerey D, Laurent-Puig P. RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study. Ann Oncol. 2018 May 1;29(5):1211-1219. doi: 10.1093/annonc/mdy061.