Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01197456
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hisu@ucsd.edu', 'phone': '858-822-5986', 'title': 'Irene Su, MD MSCE', 'organization': 'UC San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exposed/Chemotherapy', 'description': 'Breast cancer patients who will undergo chemotherapy', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 0, 'seriousNumAtRisk': 171, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Unexposed', 'description': 'Breast cancer patients who will not undergo chemotherapy', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed/Chemotherapy', 'description': 'Breast cancer patients who will undergo chemotherapy'}, {'id': 'OG001', 'title': 'Unexposed', 'description': 'Breast cancer patients who will not undergo chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 1-5', 'description': 'Number of participant without of menses for 12 months after breast cancer diagnosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '25 participants could not be evaluated for this outcome due to censoring for cancer recurrence, death, bilateral salpingo-oophorectomy, or hysterectomy.\n\n38 additional participants could not be evaluated for this outcome due to loss to follow up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposed/Chemotherapy', 'description': 'Breast cancer patients who will undergo chemotherapy'}, {'id': 'OG001', 'title': 'Unexposed', 'description': 'Breast cancer patients who will not undergo chemotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Years 1-5', 'description': 'Number of participants who experience return of menses after 3 months of amenorrhea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We did not undertake this analysis for participants who did not undergo chemotherapy (unexposed) or were censored for recurrence, death, hysterectomy or bilateral salpingo-oophorectomy (n=108) as this measure is not applicable'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exposed/Chemotherapy', 'description': 'Breast cancer patients who will undergo chemotherapy'}, {'id': 'FG001', 'title': 'Unexposed', 'description': 'Breast cancer patients who will not undergo chemotherapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exposed/Chemotherapy', 'description': 'Breast cancer patients who will undergo chemotherapy'}, {'id': 'BG001', 'title': 'Unexposed', 'description': 'Breast cancer patients who will not undergo chemotherapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '41.0', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2010-09-08', 'resultsFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-20', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis', 'timeFrame': 'Years 1-5', 'description': 'Number of participant without of menses for 12 months after breast cancer diagnosis'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea', 'timeFrame': 'Years 1-5', 'description': 'Number of participants who experience return of menses after 3 months of amenorrhea'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Ovarian insufficiency', 'Ovarian failure', 'Reproduction'], 'conditions': ['Breast Cancer', 'Ovarian Insufficiency', 'Ovarian Failure']}, 'referencesModule': {'references': [{'pmid': '25081546', 'type': 'RESULT', 'citation': 'Su HC, Haunschild C, Chung K, Komrokian S, Boles S, Sammel MD, DeMichele A. Prechemotherapy antimullerian hormone, age, and body size predict timing of return of ovarian function in young breast cancer patients. Cancer. 2014 Dec 1;120(23):3691-8. doi: 10.1002/cncr.28942. Epub 2014 Jul 31.'}, {'pmid': '28118297', 'type': 'RESULT', 'citation': 'Homer MV, Charo LM, Natarajan L, Haunschild C, Chung K, Mao JJ, DeMichele AM, Su HI. Genetic variants of age at menopause are not related to timing of ovarian failure in breast cancer survivors. Menopause. 2017 Jun;24(6):663-668. doi: 10.1097/GME.0000000000000817.'}, {'pmid': '24726216', 'type': 'RESULT', 'citation': 'Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimullerian hormone levels among commercially available immunoassays. Fertil Steril. 2014 Jun;101(6):1766-72.e1. doi: 10.1016/j.fertnstert.2014.02.046. Epub 2014 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options.\n\nThe goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of breast cancer (Stages 0-III)\n* Age \\<=45\n* Premenopausal (at least one menses over past year)\n* Has a uterus and at least one ovary\n\nExclusion Criteria:\n\n* Prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT01197456', 'acronym': 'POISE', 'briefTitle': 'Predictors of Ovarian Insufficiency in Young Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)', 'orgStudyIdInfo': {'id': 'UCSD POISE'}, 'secondaryIdInfos': [{'id': 'K23HD058799', 'link': 'https://reporter.nih.gov/quickSearch/K23HD058799', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed/chemotherapy', 'description': 'Breast cancer patients who will undergo chemotherapy'}, {'label': 'Unexposed', 'description': 'Breast cancer patients who will not undergo chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics, Gynecology, and Reproductive Sciences', 'investigatorFullName': 'Hui-Chun Irene Su', 'investigatorAffiliation': 'University of California, San Diego'}}}}