Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-31 @ 3:20 PM
Study NCT ID:
NCT04115267
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with severe side effects', 'timeFrame': '1 year', 'description': 'CTCAE V5 Grade 3-5 toxicities'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combined effect', 'Registry', 'Side effects', 'Patient reported outcome', 'Cancer'], 'conditions': ['Cancer', 'Radiotherapy Side Effect']}, 'descriptionModule': {'briefSummary': 'Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.', 'detailedDescription': 'Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.\n\nIt is within this context that this registry was set up to gather information from physicians and patients treated with molecular agents and radiation therapy. The information being collected include diagnosis, doses received, type of targeted therapy, side effects, etc. Through this registry, we wish to determine whether there are more Grade 3 or above side effects than what is reported in the literature for these treatment modalities, when given alone or in combination. Participating patients will also describe their perceived side effects and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients planned to be treated with radiotherapy and who are receiving a targeted therapy, including immunotherapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent to be part of the AtTRIBut registry\n* Prior histological diagnosis of primary cancer.\n* If the patient has metastatic disease, there must be radiological or pathological evidence of metastasis\n* Age\\> 18 years\n* Receiving a molecular therapy\n* Indicated to receive radiotherapy\n* Radiation therapy can be administered using 3D conventional, IMRT or SBRT techniques.\n\nExclusion Criteria:\n\n• Refusal or inability to receive radiotherapy'}, 'identificationModule': {'nctId': 'NCT04115267', 'acronym': 'AtTRIBut', 'briefTitle': 'Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry', 'orgStudyIdInfo': {'id': '19.065'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined modality', 'description': 'Patients receiving radiotherapy and a molecular agent for the treatment of cancer', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Anti-neoplastic Molecular Agent'], 'description': 'Combined modality', 'armGroupLabels': ['Combined modality']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mom Phat, RN', 'role': 'CONTACT', 'email': 'mom.phat.chum@ssss.gouv.qc.ca', 'phone': '514-8908000', 'phoneExt': '11171'}, {'name': 'Philip Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Mom Phat, RN', 'role': 'CONTACT', 'email': 'mom.phat.chum@ssss.gouv.qc.ca', 'phone': '1-514-8908000', 'phoneExt': '11171'}], 'overallOfficials': [{'name': 'Philip Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}