Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 2:33 AM
Study NCT ID:
NCT01614704
Status:
TERMINATED
Last Update Posted:
2019-06-20
First Post:
2012-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'whyStopped': 'End of study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline of Anti Mullerian Hormone (AMH) rate to different time points until 24 months', 'timeFrame': 'baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months', 'description': 'variation of percentages of AMH rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content'}, {'measure': 'change from baseline of account of antral follicles (CFA) rate to different time points until 24 months', 'timeFrame': 'baseline, Day 1 of Cycle 2, Day 1 of Cycle 4, Day 1 of Cycle 6, 3 months, 6 months, 9 months, 12 months, 24 months', 'description': 'variation of percentages of CFA rate compared to baseline - Observe sequential chemotherapy on ovarian follicular content'}], 'secondaryOutcomes': [{'measure': 'amenorrhea chemotherapeutically induced (weeks)', 'timeFrame': '4 years', 'description': 'observe chemotherapy induced amenorrhea frequency and duration of amenorrhea'}, {'measure': 'correlation between amenorrhea duration and oncologic outcome (overall and free disease survival)', 'timeFrame': '4 years', 'description': 'collection of amenorrhea duration (weeks)'}, {'measure': 'correlation between ovarian stimulation safety and oncologic outcome (overall and free disease survival)', 'timeFrame': '4 years', 'description': 'toxicity assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Fertility'], 'conditions': ['Breast Cancer', 'Fertility']}, 'descriptionModule': {'briefSummary': "Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate.\n\nOn 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility.\n\nFunctional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports.\n\nPrincipal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'young female, treated for non metastatic breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 ≤ age \\< 38\n* breast cancer histologically proved\n* under the control of an adjuvant chemotherapy or neo adjuvant chemotherapy\n* verbal agreement given\n\nExclusion Criteria:\n\n* age ≥ 38\n* metastatic breast cancer\n* non able to follow the design of the study (geographic, social or psychological reasons)'}, 'identificationModule': {'nctId': 'NCT01614704', 'briefTitle': 'Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility', 'orgStudyIdInfo': {'id': 'Cancer et fertilité - 1104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adjuvant treatment', 'description': 'Patients in this group will be offered the option of ovarien cryopreservation as well as the follow up of the follicule stock during chemotherapy.'}, {'label': 'Neo adjuvant treatment', 'description': 'patients in this group will only have the follow up of the follicule stock.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Oscar Lambret Center', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Audrey MAILLIEZ, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oscar Lambret Center'}, {'name': 'Christine DECANTER, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU LILLE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}