Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-28 @ 9:56 AM
Study NCT ID:
NCT01797692
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2013-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of treatments', 'timeFrame': '10 years after treatment for cancer prostate', 'description': 'The main objective of this study is to evaluate the impact of treatments and their effects on the autonomy of patients over 75 years have been treated and cured for prostate cancer.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the anxiety of patients and controls', 'timeFrame': '10 years after treatment for cancer prostate', 'description': 'Evaluate the anxiety of patients and controls'}, {'measure': 'Assessing depression patients and controls', 'timeFrame': '10 years after treatments for cancer prostate', 'description': 'Assessing depression patients and controls'}, {'measure': 'Assess the nutritional status of patients and controls', 'timeFrame': '10 years after treatments for cancer prostate', 'description': 'Assess the nutritional status of patients and controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer cured', 'aged patients'], 'conditions': ['Prostate Cancer Cured', 'Healthy Population Control']}, 'descriptionModule': {'briefSummary': 'This is a multicenter pilot study, proposed for cases and controls 3 departments in France.\n\nCases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list.\n\nVolunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.', 'detailedDescription': 'Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.\n\nDuring this consultation, ADL, IADL and MMS questionnary will be completed. neurocognitif testing will be done.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Patients aged 75 years or more\n* Patients with a personal history of prostate cancer with a diagnosis ≥ 10 years\n* Patients who received curative treatment (surgery, radiotherapy,hormone therapy, brachytherapy, technical ablative) for localized prostate cancer\n* Patients considered cured of prostate cancer (regardless of initial treatment)\n* Patients with previously agreed to participate in a case-control study in the general population (study QALIPRO) as a case and volunteer to receive an assessment of geriatric\n* Signature of consent\n* Affiliation to a social security system\n\nExclusion Criteria for patients:\n\n* Patients under 75 years\n* Patients with recurrent or metastatic\n* Persons deprived of liberty or under guardianship\n\nInclusion Criteria for control population:\n\n* Male subjects\n* Subjects of 75 years or more\n* Subjects that do not have cancer or a history of cancer (except basal cell skin cancer)\n* Subject has previously agreed to participate in a case-control study in the general population (study QALIPRO) as a voluntary witness and to benefit from a balance oncogeriatrics\n* Subjects who gave their written consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT01797692', 'acronym': 'PROGE', 'briefTitle': 'Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study', 'orgStudyIdInfo': {'id': 'PROGE'}, 'secondaryIdInfos': [{'id': '2011-A01256-35', 'type': 'OTHER', 'domain': 'ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'geriatric assessment', 'description': 'geriatric assessment', 'interventionNames': ['Other: geriatric assessment']}], 'interventions': [{'name': 'geriatric assessment', 'type': 'OTHER', 'description': 'A single geriatric assessment with a geriatrician was proposed to patients and to control population.', 'armGroupLabels': ['geriatric assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'state': 'Bas-Rhin', 'country': 'France', 'facility': 'Hopitaux universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '14076', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'Centre François BACLESSE', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '81000', 'city': 'Albi', 'country': 'France', 'facility': 'Clinique Claude BERNARD', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '81 000', 'city': 'Castres', 'country': 'France', 'facility': 'CHIC', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}