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

Conditions

Colorectal Cancer

Keywords

RAS mutation, DNA, Colorectal Cancer

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).

Bachet JB, Laurent-Puig P, Meurisse A, Bouché O, Mas L, Taly V, Cohen R, Gornet JM, Artru P, Louafi S, Thirot-Bidault A, Baumgaertner I, Coriat R, Tougeron D, Lecomte T, Mary F, Aparicio T, Marthey L, Blons H, Vernerey D, Taieb J.

2023-06-0714 citations

10.1016/j.ejca.2023.05.022

Abstract 940: Analytical and clinical validation of the Idylla™ ctKRAS and ctNRAS-BRAF liquid biopsy tests identifies mCRC patient groups with high and low ctDNA shedding

Bart Jacobs, Bart Claes, Valentina Pomella, Sabine Tejpar, Jean‐Baptiste Bachet et al. (8 authors)

Cancer Research2018-07-012 citations

10.1158/1538-7445.am2018-940

RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study

Jean‐Baptiste Bachet, Olivier Bouché, Julien Taı̈eb, Olivier Dubreuil, M. Luisa García et al. (23 authors)

Annals of Oncology2018-02-09175 citations

10.1093/annonc/mdy061

<i>RAS</i> mutations concordance in circulating tumor DNA (ctDNA) and tissue in metastatic colorectal cancer (mCRC): RASANC, an AGEO prospective multicenter study.

Jean‐Baptiste Bachet, Olivier Bouché, Julien Taı̈eb, Olivier Dubreuil, Marie‐Line Garcia et al. (20 authors)

Journal of Clinical Oncology2017-05-2011 citations

10.1200/jco.2017.35.15_suppl.11509

Evaluation of a fully automated extended <i>RAS-BRAF</i> test on prospectively collected plasma samples from patients with metastatic colorectal cancer.

Bart Jacobs, Bart Claes, Jean‐Baptiste Bachet, Olivier Bouché, Erwin Sablon et al. (7 authors)

Journal of Clinical Oncology2017-05-203 citations

10.1200/jco.2017.35.15_suppl.e15127

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods	Baseline	RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA

Secondary

Measure	Time frame	Description
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.	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).
Comparison of the timelines to obtain results between the two methods	Baseline	Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA
Comparisons of the costs between the two methods	Baseline	Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA

Countries

France

Contacts

Primary ContactJean-Baptiste Bachet, Dr

jean-baptiste.bachet@psl.aphp.fr

Outcome results