Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT03350412
Status:
UNKNOWN
Last Update Posted:
2018-10-30
First Post:
2017-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
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 and tumor specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thoroughness to report molecular profiling', 'timeFrame': '14 days from sample acquisition', 'description': 'Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition.'}], 'secondaryOutcomes': [{'measure': 'Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC', 'timeFrame': '24 months from first patient in.', 'description': 'number of patients with detected genetic alteration included in the panel (mutations and/or copy number variations) over all recruited patients.'}, {'measure': 'Percentage of complete data capture for treatment-related check-point events', 'timeFrame': 'through study completion, an average of five years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'FUNNEL population consists of individual at least 18 years of age with newly diagnosed metastatic colorectal carcinoma at the first sign of metastasis (adjuvant relapse or first diagnosis)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.\n* Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital.\n* Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year.\n* Age ≥18.\n* ECOG PS 0-1.\n* No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases.\n* Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption.\n* History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years.\n* No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT03350412', 'acronym': 'FUNNEL', 'briefTitle': 'Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials', 'orgStudyIdInfo': {'id': '007-IRCC-10IIS-14'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Ardizzoni, MD', 'role': 'CONTACT', 'email': 'andrea.ardizzoni@aosp.bo.it'}], 'facility': 'AOU Policlinico S Orsola - Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Ardizzoni, MD', 'role': 'CONTACT', 'email': 'andrea.ardizzoni@aosp.bo.it'}], 'facility': 'Policlinico S.Orsola Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '10060', 'city': 'Candiolo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Leone, MD', 'role': 'CONTACT', 'email': 'francesco.leone@ircc.it'}], 'facility': "Fondazione del Piemonte per l'Oncologia", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vittorina Zagonel, MD', 'role': 'CONTACT', 'email': 'vittorina.zagonel@iov.veneto.it'}], 'facility': 'IOV - Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Tonini, MD', 'role': 'CONTACT', 'email': 'g.tonini@unicampus.it'}], 'facility': 'Policlinico Universitario Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Massimo Aglietta, md', 'role': 'CONTACT', 'email': 'massimo.aglietta@ircc.it'}], 'overallOfficials': [{'name': 'Massimo Aglietta, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione del Piemonte per l'Oncologia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}