Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-26 @ 2:20 AM
Study NCT ID:
NCT03835520
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2018-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000276', 'term': 'Adjuvants, Immunologic'}, {'id': 'C000723989', 'term': 'Rv1579c phage protein, Mycobacterium tuberculosis'}], 'ancestors': [{'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking and allocation tbc'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:\n\n* I: Molecular targeted agent\n* II: Immunotherapy"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of treatment against Cancer', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From date of randomization until the date of first documented progression assessed up to 120 months', 'description': 'Overall survival is defined as the time from the date of inclusion to the date of death from any cause or to the date of last follow-up (in exceptional cases where it is impossible to document the date of death). Every effort should be made to document the cause of death.'}, {'measure': 'Progression free survival', 'timeFrame': 'From date of randomization until the date of first documented progression , assessed up to 120 months', 'description': 'Progression free survival (PFS) will be measured from the date of inclusion to the date of progression or death, whatever the cause.\n\nProgression will be defined according to the RECIST criteria.'}, {'measure': 'Objective tumor response', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'Objective tumor response will be measured according to the RECIST 1.1 criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Molecular Targeted Therapies', 'Tumor Biopsy', 'Plasma Samples'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.\n\nImmunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.\n\nWith the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy\n* Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction.\n* Patient able to give written informed consent.\n\nExclusion Criteria:\n\n* Patients with cancer treated with other regimen'}, 'identificationModule': {'nctId': 'NCT03835520', 'acronym': 'Plasma-Target', 'briefTitle': 'Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy', 'orgStudyIdInfo': {'id': 'UCL-ONCO 2018-02'}, 'secondaryIdInfos': [{'id': '2018/11JUI/248', 'type': 'REGISTRY', 'domain': 'Ethics Committee Approval'}, {'id': 'B403201836842', 'type': 'OTHER', 'domain': 'Belgium Registration number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOLECULAR TARGETED THERAPIES', 'description': "Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.", 'interventionNames': ['Drug: Molecular Target']}, {'type': 'EXPERIMENTAL', 'label': 'IMMUNOTHERAPY', 'description': 'Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.', 'interventionNames': ['Drug: Immunotherapeutic Agent']}], 'interventions': [{'name': 'Immunotherapeutic Agent', 'type': 'DRUG', 'description': 'Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.', 'armGroupLabels': ['IMMUNOTHERAPY']}, {'name': 'Molecular Target', 'type': 'DRUG', 'description': "Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.", 'armGroupLabels': ['MOLECULAR TARGETED THERAPIES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}