Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02502656
Status:
UNKNOWN
Last Update Posted:
2016-11-17
First Post:
2015-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood collection will be performed on the day of the first oncological consultation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 425}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance regarding the mutation of RAS (yes vs no, dichotomous variable) between the two methods', 'timeFrame': 'Baseline', 'description': 'RAS mutations will be compared between tumor tissue (standard testing methods) and results obtained from circulating tumor DNA'}], 'secondaryOutcomes': [{'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', 'description': '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).'}, {'measure': 'Comparison of the timelines to obtain results between the two methods', 'timeFrame': 'Baseline', 'description': 'Timelines to obtain RAS mutations will be compared between tumor tissue (standard testing methods) and circulating tumor DNA'}, {'measure': 'Comparisons of the costs between the two methods', 'timeFrame': 'Baseline', 'description': 'Costs for the two methods will be compared between tumor tissue (standard testing methods) and circulating tumor DNA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['RAS mutation', 'DNA', 'Colorectal Cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '37390800', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29438522', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All treatment naive patients seen in consultation for metastatic colorectal cancer in the participating centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed metachronous or synchronous metastatic colorectal cancer\n* No prior chemotherapy with the exception of adjuvant chemotherapy completed ≥ 6 months prior to enrollment\n* Signed written informed consent obtained prior to any study specific screening procedures\n* Patients willing to provide a blood sample for Translational Research\n\nExclusion Criteria:\n\n* No tumor block available\n* Previous malignancy in the last 5 years\n* Medical, sociological, psychological or legal conditions that would not permit the patient to sign informed consent'}, 'identificationModule': {'nctId': 'NCT02502656', 'acronym': 'RASANC', 'briefTitle': 'RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Association des Gastroentérologues Oncologues'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RASANC'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Aparicio, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Clamart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'L Marthey, Dr', 'role': 'CONTACT'}], 'facility': 'Hopital Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Tournigand, Pr', 'role': 'CONTACT'}], 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Thirot- Bidault, Dr', 'role': 'CONTACT'}], 'facility': 'Hopital Kremlin-Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Longjumeau', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'J Ezenfis, Dr', 'role': 'CONTACT'}], 'facility': 'CH Longjumeau et Sud', 'geoPoint': {'lat': 48.69307, 'lon': 2.29431}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gérard Lledo, Dr', 'role': 'CONTACT'}], 'facility': 'Hopital Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Coriat, Pr', 'role': 'CONTACT'}], 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry André, Pr', 'role': 'CONTACT'}], 'facility': 'Hopital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Marc Gornet, Dr', 'role': 'CONTACT'}], 'facility': 'Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Taieb, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste Bachet, Dr', 'role': 'CONTACT'}], 'facility': 'Hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Tougeron, Pr', 'role': 'CONTACT'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Bouché, Pr', 'role': 'CONTACT'}], 'facility': 'CHU Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry Lecomte, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Jean-Baptiste Bachet, Dr', 'role': 'CONTACT', 'email': 'jean-baptiste.bachet@psl.aphp.fr'}], 'overallOfficials': [{'name': 'Jean-Baptiste Bachet, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association des Gastro-entérologues Oncologues (AGEO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association des Gastroentérologues Oncologues', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}