Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03604627
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2018-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of a calcium score', 'timeFrame': 'Up to 24 months', 'description': 'Incidence of a calcium score measured by the Agatston score\\> 0 in the study population of adults treated during childhood or adolescence for cancer with irradiation of the heart area and / or treatment with anthracyclines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Cancer']}, 'descriptionModule': {'briefSummary': 'To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 18 years of age or older,\n2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years),\n3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m\\^²),\n4. In complete remission of their pediatric cancer for at least 10 years,\n5. Patient affiliated to a social security scheme or beneficiary of such a scheme,\n6. Patient Information and Signed Informed Consent.\n\nExclusion Criteria:\n\n1. Perspective less than 10 years,\n2. Persons deprived of liberty or guardianship (including trusteeship),\n3. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,\n4. Pregnant women.\n\nInclusion criteria for extension cohort:\n\n1. Patients 30 years of age or older,\n2. Treated for cancer during childhood, adolescence or young adulthood (≤25 years),\n3. Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),\n4. In complete remission of their pediatric cancer for at least 10 years,\n5. Patient affiliated to a social security scheme or beneficiary of such a scheme,\n6. Patient Information and Signed Informed Consent.\n\nExclusion criteria for extension cohort:\n\n1. Persons deprived of liberty or guardianship (including trusteeship),\n2. Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,\n3. Pregnant women.'}, 'identificationModule': {'nctId': 'NCT03604627', 'acronym': 'COROCAN', 'briefTitle': 'Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation', 'orgStudyIdInfo': {'id': '2017-A02256-47'}, 'secondaryIdInfos': [{'id': '2017/2610', 'type': 'OTHER', 'domain': 'CSET number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients treated for cancer during childhood or adolescence', 'description': 'Patients over the age of 18 treated during childhood or adolescence for cancer with irradiation affecting the heart area (≥20% of ≥5Gy heart volume) and / or anthracyclines (≥ 300mg/m\\^²)', 'interventionNames': ['Other: Coronal calcium score measurement']}], 'interventions': [{'name': 'Coronal calcium score measurement', 'type': 'OTHER', 'description': "A medical interview with clinical examination by a cardiologist for screening cardiovascular risk factors, including smoking, and looking for symptoms of heart disease as part of routine care.\n\nIn accordance with routine care, a fasting and fasting blood test will be performed performed on exam day at Bichat Hospital or at another time, close to the patient's home according to his availability. The biological blood test will include the measurement of plasma triglyceride concentrations, total cholesterol and its HDL and LDL fractions, blood glucose, glycated hemoglobin and serum creatinine with estimated glomerular filtration rate according to the CKD-EPI formula. Sample urinalysis will include measurement of creatinine, proteinuria, and microalbuminuria.\n\nAn electrocardiogram (ECG) rest, a cardiac ultrasound, a test and respiratory function tests (EFR) will be performed as part of routine care. Coronal calcium score measurement will be performed as part of the research.", 'armGroupLabels': ['Patients treated for cancer during childhood or adolescence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'state': 'Val De Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brice FRESNEAU, MD', 'role': 'CONTACT', 'email': 'brice.fresneau@gustaveroussy.fr', 'phone': '+33 (0)1 42 11 42 11'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence Arnoult, MD', 'role': 'CONTACT', 'email': 'florence.arnoult@aphp.fr', 'phone': '+33 (0)1 40 25 84 01'}], 'facility': 'Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Dominique Tabone, MD', 'role': 'CONTACT', 'email': 'marie-dominique.tabone@trs.aphp.fr', 'phone': '+33 (0)1 44 73 68 46'}], 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Brice FRESNEAU, MD', 'role': 'CONTACT', 'email': 'brice.fresneau@gustaveroussy.fr', 'phone': '+33 (0)1 42 11 42 11'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}