Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT01082757
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1524}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-30', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene', 'timeFrame': 'Initial visit (Day 1) and subsequent visit till the end of the study'}], 'secondaryOutcomes': [{'measure': 'Subject and tumour characteristics and their association with KRAS mutational status', 'timeFrame': 'Initial visit (Day 1) and subsequent visit till the end of the study'}]}, 'conditionsModule': {'keywords': ['Colorectal neoplasms', 'metastasis', 'colorectal cancer'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.', 'detailedDescription': 'This is an observational, prospective, non-interventional, single arm, non-comparative, open label, multi-centric, multi-stage study to record the prevalence of KRAS mutations in the Argentine mCRC population. The study is planned to be conducted in 150 centres (50 in each of 3 stages of four months each, enrolling 500 subjects in each stage). Total of subjects: 1500. Demographic information, complete medical history and tumour history related data will be captured in the first visit and if any information is missing, then only another visit will be scheduled. Data captured will be analysed and presented using statistical tools.\n\nOBJECTIVES:\n\nPrimary objective:\n\n* To record the prevalence of KRAS mutations in the Argentine mCRC population.\n\nSecondary objective:\n\n* To record and evaluate certain subject and tumour characteristics for association with KRAS mutational status (country, gender, age, performance status, body mass index (BMI), ethnic origin, personal and family history of malignancy, personal and family history of familial polyposis coli, smoking status, exercise, diet, tumour characteristics/location, site of origin of the tissue sample sent for KRAS testing, first line therapy chosen).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with histologicaly confirmed metastatic adenocarcinoma of the colon/rectum in Argentina', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have signed written informed consent before any study-related procedure\n* Subjects with histologically confirmed adenocarcinoma of the colon/ rectum, T1-4 N0-2 M1 or rT1-4 N0-2 M1\n* Subjects with age above 21 years\n* Subjects willing to provide information required by protocol\n* No previous systemic treatment for mCRC\n\nExclusion Criteria:\n\n* Subjects with known pregnancy\n* Subjects with previous systemic therapy for mCRC\n* Subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study\n* Subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent'}, 'identificationModule': {'nctId': 'NCT01082757', 'briefTitle': 'Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients', 'orgStudyIdInfo': {'id': 'EMR62202-513'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vicente López', 'country': 'Argentina', 'facility': 'Htal Vicente Lopez', 'geoPoint': {'lat': -34.52947, 'lon': -58.4737}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Quimica Argentina S.A.I.C'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Quimica Argentina S.A.I.C', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}