Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-30 @ 8:50 PM
Study NCT ID:
NCT01723969
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2012-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Platform for Clinical Trials in Advanced 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': 'FFPE blocks of tumour tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 668}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2012-11-05', 'studyFirstSubmitQcDate': '2012-11-06', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumour markers assessment', 'timeFrame': 'Within 1 week after patient registration', 'description': 'Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Advanced Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.\n\nCurrently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.\n\nA major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.\n\nThe EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced or metastatic colo-rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Colo-rectal cancer (advanced or metastatic)\n* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.\n\nExclusion Criteria:\n\n* Absence of patient's consent"}, 'identificationModule': {'nctId': 'NCT01723969', 'acronym': 'SPECTAcolor', 'briefTitle': 'Screening Platform for Clinical Trials in Advanced Colorectal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"', 'orgStudyIdInfo': {'id': 'EORTC-40CRC'}, 'secondaryIdInfos': [{'id': '2012-003714-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colo-rectal cancer', 'description': 'Tumour markers testing in patients with advanced or metastatic colo-rectal cancer', 'interventionNames': ['Genetic: Tumour markers testing']}], 'interventions': [{'name': 'Tumour markers testing', 'type': 'GENETIC', 'description': 'Tumour markers testing in patients advanced or metastatic colo-rectal cancer.', 'armGroupLabels': ['Colo-rectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2006', 'city': 'Stróvolos', 'country': 'Cyprus', 'facility': 'Bank Of Cyprus Oncology Centre', 'geoPoint': {'lat': 35.14867, 'lon': 33.33384}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy Cancer Campus', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': 'DE 01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitaetsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaets-Krankenhaus Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'DE 04205', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitaetsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'DE 81377', 'city': 'München', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'DE 26133', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Kliniken Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': 'GR 71110', 'city': 'Heraklion', 'country': 'Greece', 'facility': 'University General Hospital Heraklion', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Seconda Universita Degli Studi Di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': 'PL 61 866', 'city': 'Poznan', 'country': 'Poland', 'facility': 'The Great Poland Cancer Centre', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': 'PL 02 781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Memorial Cancer Centre', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'PT 1099-023', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'I.P.O. Francisco Gentil - Centro De Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': 'ES 08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital General Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'ES 08907', 'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': "Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': 'ES 28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'ES 28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 De Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SE 41685', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Ostra Sjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'CH-1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'CH 1951', 'city': 'Sion', 'country': 'Switzerland', 'facility': 'Hopital du Valais - Hopital de Sion', 'geoPoint': {'lat': 46.22739, 'lon': 7.35559}}, {'zip': 'CH 8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitaetsSpital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Gunnar Folprecht, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaetsklinikum Carl Gustav Carus, Dresden, DE'}, {'name': 'Sabine Tejpar, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'U.Z. Leuven - Campus Gasthuisberg, Leuven, BE'}, {'name': 'Daniela Aust, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitaetsklinikum Carl Gustav Carus, Dresden, DE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}