Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT06048458
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2022-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in myocardial blood flow from baseline with adenosine stress assessed by quantitative perfusion cardiac MRI', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in left ventricular ejection fraction from baseline', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in left ventricular extracellular volume from baseline', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in left ventricular global longitudinal strain from baseline', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in N-terminal pro B-type natriuretic peptide (NT-pro BNP)', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in high sensitivity troponin T', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in sublingual perfused boundary region', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in sublingual capillary density', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}, {'measure': 'Change in retinal vessel density', 'timeFrame': '6 months', 'description': 'Assessed at baseline, following cycle 1 and 4-6 weeks post completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardio-oncology', 'Cardiotoxicity', 'Fluoropyrimidine cardiotoxicity'], 'conditions': ['Cardiovascular Diseases', 'Cardiotoxicity', 'Fluorouracil Adverse Reaction', 'Malignancy', 'Colorectal Cancer', 'Oesophagus Cancer', 'Gastric Cancer', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.', 'detailedDescription': 'Fluoropyrimidine (5-FU and Capecitabine) based chemotherapy regimens form the cornerstone of treatments for gastrointestinal (GI) cancers. Fluoropyrimidines however, are associated with the development of cardiovascular toxicity which can take on different forms including chest pain, myocardial infarction, arrhythmias, heart failure and sudden death. The underlying mechanisms of cardiovascular toxicity are not fully understood.\n\nThe investigators will use quantitative cardiovascular magnetic resonance perfusion imaging, CT coronary angiography, extra-cardiac vascular assessments and serum cardiac biomarkers to improve insights into the pathophysiology of fluoropyrimidine cardiotoxicity. All enrolled participants in this two centre study will have GI cancers requiring treatment with fluoropyrimidine chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with gastrointestinal malignancies being treated with a fluoropyrimidine based chemotherapy regimen.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Gastrointestinal malignancy\n* Receiving fluoropyrimidine chemotherapy\n\nExclusion Criteria:\n\n* Participants unable or unwilling to provide consent\n* Participants that have a conventional contraindication for magnetic resonance imaging (MRI) including permanent implantable cardiac devices, ferromagnetic implants, pregnancy, large body size not fitting into the scanner bore and severe claustrophobia will be excluded\n* Participants that have a conventional contraindication for adenosine stress perfusion including a history of trifascicular block or of second-degree heart block or higher on ECG, or uncontrolled asthma.\n* Participants with significant renal impairment (eGFR\\<30ml/min)\n* History of allergy to adenosine, gadolinium or iodinated contrast\n* Patients with terminal illness (life expectancy \\<6 months) will be excluded.'}, 'identificationModule': {'nctId': 'NCT06048458', 'acronym': 'PC-TOX', 'briefTitle': 'Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping', 'orgStudyIdInfo': {'id': '142669'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Stable patients with gastrointestinal malignancies will be recruited to this 3 timepoint study prior to initiation of fluoropyrimidine chemotherapy. All investigations will be performed at baseline, at the end of cycle 1 and 4-6 weeks post completion of treatment.', 'interventionNames': ['Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion', 'Diagnostic Test: CT coronary angiography', 'Diagnostic Test: Retinal OCT angiography', 'Diagnostic Test: Sublingual microscopy (GlycoCheck)', 'Diagnostic Test: Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)']}, {'label': 'Cohort 2', 'description': 'Patients with gastrointestinal malignancies presenting to hospital with acute symptoms of fluoropyrimidine cardiotoxicity. All investigations will be performed during the acute presentation and the second visit will be performed 4-6 weeks post completion of treatment.', 'interventionNames': ['Diagnostic Test: Cardiovascular magnetic resonance with stress perfusion', 'Diagnostic Test: CT coronary angiography', 'Diagnostic Test: Retinal OCT angiography', 'Diagnostic Test: Sublingual microscopy (GlycoCheck)', 'Diagnostic Test: Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)']}], 'interventions': [{'name': 'Cardiovascular magnetic resonance with stress perfusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiac MRI scan to assess changes in left ventricular function, parametric mapping, strain and myocardial blood flow. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'CT coronary angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT coronary angiogram at baseline only in both cohorts to assess for coronary artery disease', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Retinal OCT angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Retinal OCTa to assess changes in retinal vasculature. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Sublingual microscopy (GlycoCheck)', 'type': 'DIAGNOSTIC_TEST', 'description': 'To determine changes in sublingual microvascular health. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Serum cardiac biomarkers (High sensitivity troponin, NT pro BNP)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Performed to assess for myocardial injury. In cohort 1 this will be performed pre, during and on completion of treatment. In cohort 2 this will be performed during the acute presentation and on completion of treatment.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Aderonke Abiodun, MBChB', 'role': 'CONTACT', 'email': 'aderonketemilade.abiodun@nhs.net'}, {'name': 'Charlotte Manisty, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Malcolm Walker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Bartholomews Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Aderonke Abiodun, MBChB', 'role': 'CONTACT', 'email': 'aderonketemilade.abiodun@nhs.net', 'phone': '02073777000'}], 'overallOfficials': [{'name': 'Charlotte Manisty, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}