Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 4:00 AM
Study NCT ID:
NCT05007834
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2021-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolism, Circadian Rhythms and Ovarian Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of IL-6 levels at the end of chemotherapy', 'timeFrame': '1 year', 'description': 'Study the association between the IL-6 blood levels (in pg/ml) at the end of chemotherapy and the menstrual period return state ( before or after 6 months)'}], 'secondaryOutcomes': [{'measure': 'Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state', 'timeFrame': '1 year', 'description': 'Leptin concentration in ng/ml; insulin concentration in mUI/L; ghrelin concentrations in pg/ml'}, {'measure': 'Correlation between physical activity score at the end of chemotherapy and menstrual period return state', 'timeFrame': '1 year', 'description': 'Physical activity score expressed in arbitrary units'}, {'measure': 'Correlation between chronotype score at the end of chemotherapy and menstrual period return state', 'timeFrame': '1 year', 'description': 'chronotype score expressed in arbitrary units'}, {'measure': 'Correlation between the BMI at the end of chemotherapy and menstrual period return state', 'timeFrame': '1 year', 'description': 'weight and height will be combined to report BMI in kg/m2'}, {'measure': 'Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state', 'timeFrame': '9 months', 'description': 'Leptin concentration in ng/ml, Insulin concentration in mUI/L, Ghrelin concentration in pg/ml'}, {'measure': 'Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months)', 'timeFrame': '9 months', 'description': 'Physical activity score expressed in arbitrary units'}, {'measure': 'Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months)', 'timeFrame': '9 months', 'description': 'weight and height assessed at 3 months will be combined to report BMI in kg/m2'}, {'measure': 'Evolution of the blood concentration of insulin over the follow-up period (12 months)', 'timeFrame': '1 year', 'description': 'insulin concentrations expressed in mUI/L'}, {'measure': 'Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months)', 'timeFrame': '9 months', 'description': 'chronotype score expressed in arbitrary units'}, {'measure': 'Evolution of the blood concentration of Leptin over the follow-up period (12 months)', 'timeFrame': '1 year', 'description': 'leptin concentrations expressed in ng/ml'}, {'measure': 'Evolution of the blood concentration of Ghrelin over the follow-up period (12 months)', 'timeFrame': '1 year', 'description': 'ghrelin concentrations expressed in pg/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian recovery', 'Metabolism', 'Muscular mass', 'Adipose tissue', 'Chronotype'], 'conditions': ['Chemotherapy-Induced Amenorrhea']}, 'descriptionModule': {'briefSummary': 'Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a fertility evaluation within five years of diagnosis. Predicting the risk and especially the duration of the CIA remains difficult. Known factors predicting a rapid return of menstruation are a young age at diagnosis, a low gonadotoxic treatment (absence of alkylating agents) and a high pre-chemotherapy blood level of AMH reflecting a large pool of growing follicles. A body mass index (BMI) ≥ 25 kg / m² could also be a positive predictor, but this remains debated.\n\nThe objective of this project is to assess the impact of metabolism and energy reserves, physical activity and the chronotype on the recovery of ovarian function in patients with breast cancer who have developed CIA'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.', 'genderDescription': 'Women with a chemotherapy-induced (CIA) amenorrhea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.\n* Women between 25 to 35 years age at inclusion\n* Chemotherapy protocol: FEC 100 (3 cycles) + docetaxel (3 cycles\n\nExclusion Criteria:\n\n* Women without CIA\n* Women who refuse to participate in the study\n* Women older than 35 years at inclusion\n* Women who received another chemotherapy protocol'}, 'identificationModule': {'nctId': 'NCT05007834', 'acronym': 'METAB-OV', 'briefTitle': 'Metabolism, Circadian Rhythms and Ovarian Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer', 'orgStudyIdInfo': {'id': '2020_16'}, 'secondaryIdInfos': [{'id': '2021-A00461-40', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hop Jeanne de Flandre Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Pascal PIGNY, MD,PhD', 'role': 'CONTACT', 'email': 'pascal.pigny@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Pascal PIGNY, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}