Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT00705094
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2008-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D018239', 'term': 'Seminoma'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018237', 'term': 'Germinoma'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2008-06-23', 'studyFirstSubmitQcDate': '2008-06-24', 'lastUpdatePostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular risk factors', 'cardiac function', 'VO2peak', 'Chemotherapy'], 'conditions': ['Testicular Cancer', 'Seminoma', 'Non-seminomatous']}, 'descriptionModule': {'briefSummary': 'For many years, researchers and doctors have studied different kinds of treatments to improve the survival of men with testicular cancer. However, recent research has shown that many years later, men who had testicular cancer appear to be at higher risk for developing heart disease (heart attack or heart failure), especially if they received chemotherapy. Since these studies were done many years after men received treatment, there was no way to know if other factors contributed to the health problems they experienced. This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.', 'detailedDescription': 'The aim of this pilot study is to examine global and regional LV systolic and diastolic function, cardiac output, cardiac reserve, VO2peak and CVD risk profile in males recently diagnosed with testicular cancer treated with surgery alone or surgery and chemotherapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'testicular cancer patients who have recieved surgery and are scheduled for either chemotherapy or surveillance', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery and surveillance\n* surgery and multi-cycle chemotherapy\n* both good and intermediate prognosis seminoma and non-seminomatous germ cell testicular tumors\n* Karnofsky performance index \\> 70%\n* no contraindications to cardiopulmonary testing\n\nExclusion Criteria:\n\n* documented cardiovascular disease or evidence of myocardial ischemia on the incremental exercise (VO2peak) test.'}, 'identificationModule': {'nctId': 'NCT00705094', 'briefTitle': 'Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'AHS Cancer Control Alberta'}, 'officialTitle': 'Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients', 'orgStudyIdInfo': {'id': 'GU-24167'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Testicular cancer patients who have received surgery and are scheduled for surveillance'}, {'label': '2', 'description': 'Testicular cancer patients who have received surgery and are scheduled for chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Mark Haykowsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHS Cancer Control Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}