Colorectal CancerRASANCNCT02502656
RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer
An observational study of Colorectal Cancer, run by Association des Gastroentérologues Oncologues at 14 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 425 participants
- Where
- 14 sitesFrance
- Study dates
- Jul 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
Jean-Baptiste Bachet, Dr contact
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Hôpital Avicenne
Bobigny
Thomas Aparicio, Pr
- Recruiting
Hopital Béclère
Clamart
L Marthey, Dr
- Recruiting
Hopital Henri Mondor
Créteil
Christophe Tournigand, Pr
- Recruiting
Hopital Kremlin-Bicêtre
Le Kremlin-Bicêtre
Anne Thirot- Bidault, Dr
- Recruiting
CH Longjumeau et Sud
Longjumeau
J Ezenfis, Dr
- Recruiting
Hopital Mermoz
Lyon
Gérard Lledo, Dr
- Recruiting
Hopital Cochin
Paris
Romain Coriat, Pr
- Recruiting
Hopital Saint-Antoine
Paris
Thierry André, Pr
- Recruiting
Hopital Saint-Louis
Paris
Jean-Marc Gornet, Dr
- Recruiting
Hôpital Européen Georges Pompidou
Paris
Julien Taieb, Pr
- Recruiting
Hôpital Pitié Salpêtrière
Paris
Jean-Baptiste Bachet, Dr
- Recruiting
CHU Poitiers
Poitiers
David Tougeron, Pr
- Recruiting
CHU Robert Debré
Reims
Olivier Bouché, Pr
- Recruiting
Hôpital Trousseau
Tours
Thierry Lecomte, Pr
About this study
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
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).
- Conditions
- Colorectal Cancer
- Keywords
- RAS mutation, DNA, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (3)
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).
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association des Gastroentérologues Oncologues
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Bachet, Dr, Principal investigator, Association des Gastro-entérologues Oncologues (AGEO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502656
- Sponsor's protocol ID
- RASANC
- Acronym
- RASANC
- Status last verified
- Nov 2016
- First submitted
- 16 Jul 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bachet JB, Laurent-Puig P, Meurisse A, Bouche 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. Circulating tumour DNA at baseline for individualised prognostication in patients with chemotherapy-naive metastatic colorectal cancer. An AGEO prospective study. Eur J Cancer. 2023 Aug;189:112934. doi: 10.1016/j.ejca.2023.05.022. Epub 2023 Jun 7.
PubMed 37390800Bachet 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.
PubMed 29438522
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02502656
- Acronym / sponsor ID
- RASANC / RASANC
- Conditions
- Colorectal Cancer
- Keywords
- RAS mutation, DNA, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Association des Gastroentérologues OncologuesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Comparison of the timelines to obtain results between the two methods
Time frame: Baseline
Comparisons of the costs between the two methods
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Derived from this study: PubMed 37390800Bachet JB, Laurent-Puig P, Meurisse A, Bouche 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. Circulating tumour DNA at baseline for individualised prognostication in patients with chemotherapy-naive metastatic colorectal cancer. An AGEO prospective study. Eur J Cancer. 2023 Aug;189:112934. doi: 10.1016/j.ejca.2023.05.022. Epub 2023 Jun 7.
- Derived from this study: PubMed 29438522Bachet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste Bachet, Dr contact
Jean-Baptiste Bachet, Dr principal investigator
Association des Gastro-entérologues Oncologues (AGEO)
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Association des Gastroentérologues Oncologues at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste Bachet, Dr (jean-baptiste.bachet@psl.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502656, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.