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

Colorectal Cancer Clinical Trial

— RASANC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02502656
• Other study ID #: RASANC
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2015
• Last updated: November 16, 2016
• Start date: July 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: Association des Gastroentérologues Oncologues
• Contact: Jean-Baptiste Bachet, Dr
• Email: jean-baptiste.bachet[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Hopital Béclère	Clamart
France	Hopital Henri Mondor	Creteil
France	Hopital Kremlin-Bicêtre	Kremlin-Bicêtre
France	CH Longjumeau et Sud	Longjumeau
France	Hopital Mermoz	Lyon
France	Hopital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Hopital Saint-Antoine	Paris
France	Hopital Saint-Louis	Paris
France	CHU Poitiers	Poitiers
France	CHU Robert Debré	Reims
France	Hôpital Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Association des Gastroentérologues Oncologues

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods	RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA	Baseline	No
Secondary	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.	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	No
Secondary	Comparison of the timelines to obtain results between the two methods	Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA	Baseline	No
Secondary	Comparisons of the costs between the two methods	Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA	Baseline	No