Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-26 @ 9:10 PM
Study NCT ID:
NCT03114618
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2017-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EDTA Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous thromboembolism events', 'timeFrame': 'During the 18 months of follow up', 'description': 'The development of venous thromboembolism will be registered'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Venous thrombosis', 'Cancer', 'Risk Model Assessment', 'Genomic'], 'conditions': ['Cancer-associated Thrombosis', 'Genetic Predisposition']}, 'referencesModule': {'references': [{'pmid': '25341889', 'type': 'RESULT', 'citation': 'Soria JM, Morange PE, Vila J, Souto JC, Moyano M, Tregouet DA, Mateo J, Saut N, Salas E, Elosua R. Multilocus genetic risk scores for venous thromboembolism risk assessment. J Am Heart Assoc. 2014 Oct 23;3(5):e001060. doi: 10.1161/JAHA.114.001060.'}, {'pmid': '25652150', 'type': 'RESULT', 'citation': 'Rubio-Terres C, Soria JM, Morange PE, Souto JC, Suchon P, Mateo J, Saut N, Rubio-Rodriguez D, Sala J, Gracia A, Pich S, Salas E. Economic analysis of thrombo inCode, a clinical-genetic function for assessing the risk of venous thromboembolism. Appl Health Econ Health Policy. 2015 Apr;13(2):233-42. doi: 10.1007/s40258-015-0153-x.'}, {'pmid': '29588512', 'type': 'RESULT', 'citation': 'Munoz Martin AJ, Ortega I, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ruperez A, Souto JC, Martin M, Salas E, Soria JM. Multivariable clinical-genetic risk model for predicting venous thromboembolic events in patients with cancer. Br J Cancer. 2018 Apr;118(8):1056-1061. doi: 10.1038/s41416-018-0027-8. Epub 2018 Mar 28.'}, {'pmid': '36730884', 'type': 'DERIVED', 'citation': 'Munoz A, Ay C, Grilz E, Lopez S, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ortega L, Ruperez A, Salas E, Pabinger I, Soria JM. A Clinical-Genetic Risk Score for Predicting Cancer-Associated Venous Thromboembolism: A Development and Validation Study Involving Two Independent Prospective Cohorts. J Clin Oncol. 2023 Jun 1;41(16):2911-2925. doi: 10.1200/JCO.22.00255. Epub 2023 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients are receiving chemotherapy. Current risk scores for predicting cancer-associated VTE in ambulatory patients had low/moderate discrimination and clinical sensitivity. These models use clinical and biochemical parameters of the patient.\n\nIn the development of VTE genetics play a relevant role. The product Thrombo inCode (TiC) assess VTE risk prediction by using a combination of a genetic risk score (GRS) and clinical parameters from the patient. The investigators hypothesized that the GRS included in TiC combined with clinical parameter some of them associated with cancer could be better predicted by TiC than by current risk scores (Khorana score).\n\nAfter publishing the primary results in 2018, we have expanded the GRS in a external validation cohort adding gliomas and biliary tract tumors. Also we have incorporated the assessment of D-dimer in order to improve the predictive capability.', 'detailedDescription': 'The working hypothesis of this study establishes that the risk of cancer patients suffering a thromboembolic event is conditioned by individual genomic factors. The genes to be analyzed have clearly demonstrated their relationship with thromboembolic disease in other clinical contexts. This study is considered the initiation of a field of research in genomic risk markers indicating a risk of thrombosis in cancer patients. The ultimate goal of the study is to establish a clinic-genomic score for selecting patients with a high risk of suffering thrombotic events who can benefit from guided thromboprophylaxis. Its secondary goal is to prevent the adverse effects of ineffective therapies in other patients (low-risk patients not requiring an anti-thrombotic prophylaxis).\n\nThe aim is to demonstrate the link between the clinic-genetic profile and the risk of suffering thromboembolic events in the group of cancer patients. The working hypothesis establishes that cancer patients who develop thrombotic events will have a higher score for the thrombosis risk clinic-genetic profile than cancer patients not developing thromboembolic events. The second aim is to analyze whether the thrombosis clinic-genetic risk score improves the detection of patients at risk of suffering a thromboembolic event compared to the Khorana predictive model routinely used (Khorana score).\n\nCurrent validations ongoing:\n\nAn external retrospective validation adding 250 patients more and including D-dimer and other types of high-risk neoplasm.\n\nAn external prospective validation (second ONCOTRHROMB12-01 cohort 2) adding 450 patients more and including D-dimer and other types of high-risk neoplasm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients diagnosed with colorectal, esophago-gastric, biliary tract, pancreas or lung cancer who have not previously been treated with chemotherapy or chemotherapy and radiation therapy and are candidate for chemotherapy in outpatient setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients treated in outpatient clinics with a documented histological or cytological diagnosis for non-microcytic lung, colorectal, biliary tract cancer, pancreatic or esophago-gastric cancer at an advanced stage, locally advanced or localized not previously treated with systemic chemotherapy and/or radiation therapy who are candidate for chemotherapy in outpatient setting.\n* Performance status 0-2.\n* Patients signing the study informed consent form.\n\nExclusion Criteria:\n\n* Life expectancy of less than 3 months.\n* Patients undergoing anti-coagulant treatment before the cancer diagnosis for reasons other than a concurrent venous thromboembolic event.'}, 'identificationModule': {'nctId': 'NCT03114618', 'acronym': 'ONCOTHROMB', 'briefTitle': 'A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Genomic Predictors Indicating the Risk of Venous Thromboembolic Disease in Cancer Patients Treated in Outpatient Clinics', 'orgStudyIdInfo': {'id': 'ONCOTHROMB12-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Almería', 'state': 'Almería', 'country': 'Spain', 'facility': 'Complejo Hospitalario Torrecárdenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Fuenlabrada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario la Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Ourense', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Orense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}], 'overallOfficials': [{'name': 'Andrés J. Muñoz Martín, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario Gregorio Marañón'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andres muñoz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Servicio de Oncología Médica. HGU Gregorio Marañón. Madrid', 'class': 'UNKNOWN'}, {'name': "Unitat de Genòmica de Malalties Complexes. Institut d'Investigació Sant Pau", 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Hospital Universitario de Fuenlabrada', 'class': 'OTHER'}, {'name': 'Hospital Universitario Marqués de Valdecilla', 'class': 'OTHER'}, {'name': 'Complexo Hospitalario de Ourense', 'class': 'OTHER'}, {'name': 'Complejo Universitario Torrecárdenas, Almería', 'class': 'UNKNOWN'}, {'name': 'Gendiag', 'class': 'INDUSTRY'}, {'name': 'Ferrer inCode, S.L.', 'class': 'INDUSTRY'}, {'name': "Unitat d'Hemostasia i Trombosi. Hospital de la Santa Creu i Sant Pau", 'class': 'UNKNOWN'}, {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, {'name': 'Sociedad Española de Trombosis y Hemostasia (SETH)', 'class': 'UNKNOWN'}, {'name': 'Sociedad Española de Oncología Médica (SEOM)', 'class': 'UNKNOWN'}, {'name': 'University Hospital Virgen de las Nieves', 'class': 'OTHER'}, {'name': 'Hospital Obispo Polanco, Teruel', 'class': 'UNKNOWN'}, {'name': 'Complejo Hospitalario Universitario de Vigo', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Hospital General de Ciudad Real', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Andres muñoz', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}