Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT01960634
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2013-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BRAF V600 blood levels and illness evolution', 'timeFrame': 'two years'}, {'measure': 'NRAS and p61BRAFFV600 serum levels and clinic evolution', 'timeFrame': 'two years'}, {'measure': 'BRAFV600 blood levels vs progression-free survival', 'timeFrame': 'two years'}], 'primaryOutcomes': [{'measure': 'Rate of patient in which BRAF V600 in blood samples is present/absent', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with BRAFV600 present in tumor sample vs blood sample', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage IV Skin Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.\n\nSamples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.\n\nThe treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically confirmed melanoma and BRAF V600 mutation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of melanoma and BRAFV600\n* Signed Informed Consent Form\n* Unresectable phase III or phase IV melanoma\n* The patients should be starting a treatment for melanoma (either first line or subsequent lines)'}, 'identificationModule': {'nctId': 'NCT01960634', 'acronym': 'BRAFV600', 'briefTitle': 'Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Español Multidisciplinar de Melanoma'}, 'officialTitle': 'Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'GEM-1304'}, 'secondaryIdInfos': [{'id': 'GEM-1304', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06080', 'city': 'Madrid', 'state': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08028', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Quirón Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '35001', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Hospital Insular de Gran Canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del SOl', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'city': 'Toledo', 'state': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Fundación Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'María González Cao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Quirón Dexeus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Español Multidisciplinar de Melanoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}