Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT01415258
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2011-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the Vulnerable Elders Survey score (VES-13)', 'timeFrame': 'Within 3 months after recruitment', 'description': 'A patient is identified vulnerable if the score is ≥ 3'}], 'secondaryOutcomes': [{'measure': 'To assess the correlation between the VES-13 score and the vulnerability judged by a clinical expert', 'timeFrame': 'Within 3 months after recruitment', 'description': 'A patient will be identified as vulnerable if he/she belongs to the "intermediate" or "frail" category. The Kappa coefficient of agreement will be used to correlate the VES-13 score and clinical observations.'}, {'measure': 'To measure the muscle strength using the grip strength test', 'timeFrame': 'Within 3 months after recruitment', 'description': 'Hand Dynamometer Range values : 0-90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'vulnerability', 'frail'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).\n\nThe objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study concerns elderly patients (≥70 years) with solid tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient aged ≥ 70\n* coming for a first visit, whatever the purpose and the disease stage\n\nExclusion Criteria:\n\n* neglect or refusal to answer to the VES-13 test'}, 'identificationModule': {'nctId': 'NCT01415258', 'briefTitle': 'Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre', 'orgStudyIdInfo': {'id': 'VULNERABILITE-1103'}}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Oscar Lambret Anti-Cancer Centre', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Véronique SERVENT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oscar Lambret Anti-Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital Gériatrique Les Bateliers, CHRU Lille', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}