Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 10:51 AM
Study NCT ID:
NCT01333735
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2011-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'NFS, uree, creatinin, ASAT, ALAT, PAL, GGT, Vit D, B12, Folates, Albumin, lipid, TSH, testosteron, oestradiol, LH, FSH, TP, TCA, D-Dimeres, Homocystéine, plasmatic biomarkers(protein S100, NSE, CRP, IL6)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2011-04-08', 'studyFirstSubmitQcDate': '2011-04-11', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of memory impairment', 'timeFrame': 'Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy', 'description': 'Assessing the impact of memory impairment induced by chemotherapy and study their evolution over time, with patients over 65 years treated in the adjuvant setting for breast cancer.\n\nEvaluated by auto-questionnary an tests with a neuropsychologist'}], 'secondaryOutcomes': [{'measure': 'correlations between disorders of cognitive functions and parameters of quality of life', 'timeFrame': 'Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy', 'description': 'Studying the correlations between disorders of cognitive functions and parameters of quality of life'}, {'measure': 'Relationship between performance and onco-geriatric cognitive', 'timeFrame': 'Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy', 'description': 'Examine the relationship between performance and onco-geriatric cognitive'}, {'measure': 'Biological disturbances', 'timeFrame': 'Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy', 'description': 'Search for biological disturbances may be related to cognitive impairment observed'}, {'measure': 'Impact of age', 'timeFrame': 'Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy', 'description': 'Assess the impact of age on the magnitude of cognitive impairment in patients'}, {'measure': 'lived of the entourage', 'timeFrame': 'Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy', 'description': "\\- Assess the impact and cognitive impairment of patients'experiences of the circle (translational research)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive functions', 'quality of life', 'breast cancer', 'chemotherapy', 'ages patients'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive function in patients aged over 65 and suffering from breast cancer or colon.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chemotherapy group and patients without chemotherapy group (control group)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for patients with chemotherapy :\n\n* Patient(e) aged over 65 years\n* Non metastatic breast cancer\n* Adjuvant chemotherapy Breast cancer: FEC, including Docetaxel Protocols\n* No major cognitive impairment\n* Lack of personality disorders and psychiatric disorders evolutionary\n* Having signed the informed consent of study participation\n\nInclusion Criteria for patients without chemotherapy (control group):\n\n* Patient(e) aged over 65 years\n* Breast cancer\n* Patients receiving no adjuvant chemotherapy\n* No major cognitive impairment\n* Lack of personality disorders and psychiatric disorders evolutionary\n* Having signed the informed consent of study participation\n* Matching on age, sex, cultural level and tumor location\n\nExclusion Criteria for patients with chemotherapy :\n\n* Metastatic\n* Cancer primitive other than breast\n* Patients under 65 years\n* Patients with adjuvant chemotherapy is associated with targeted therapy\n* Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)\n* disorders of higher functions existing in the administration of chemotherapy\n* Pathology psychiatric evolutionary\n* Refusal of participation\n* Patients unable to meet the cognitive tests\n* Drug use\n* Heavy drinking'}, 'identificationModule': {'nctId': 'NCT01333735', 'acronym': 'COG AGE', 'briefTitle': 'Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon', 'orgStudyIdInfo': {'id': 'COG AGE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chemotherapy group', 'description': 'Patients with breast or colon cancer must beginning a chemotherapy (colon group was ended)'}, {'label': 'Patients without chemotherapy group', 'description': 'patient with breast or colon cancer should not receive chemotherapy (colon group was ended)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Université', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'INSERM', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14033', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14076', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'Centre François BACLESSE', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59000', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'CHRU Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Hopital gériatrique des Bateliers', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59653', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Université', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76000', 'city': 'Rouen', 'state': 'Seine Maritime', 'country': 'France', 'facility': 'CHU, Hôpital Bois Guillaume', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '76000', 'city': 'Rouen', 'state': 'Seine Maritime', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '76038', 'city': 'Rouen', 'state': 'Seine Maritime', 'country': 'France', 'facility': 'Centre Henri BECQUEREL', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '94206', 'city': 'Ivry-sur-Seine', 'country': 'France', 'facility': 'Hôpital Charles FOIX', 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopitaux universitaires', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '75475', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hopital Pitié-Sapètrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hopital TENON', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Florence JOLY-LOBBEDEZ, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre François Baclesse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Pr Florence JOLY-LOBBEDEZ', 'oldOrganization': 'Centre François Baclesse'}}}}