Ignite Creation Date:
2025-12-17 @ 3:18 PM
Ignite Modification Date:
2025-12-23 @ 4:55 PM
Study NCT ID:
NCT00735150
Status:
COMPLETED
Last Update Posted:
2010-10-11
First Post:
2008-08-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian 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'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-08', 'studyFirstSubmitDate': '2008-08-12', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To explore the attitudes of BRCA1/2 mutation carriers about PGD/PND, most notably benefits and drawbacks, as well as ethical and emotional considerations;', 'timeFrame': 'conclusion of study'}], 'secondaryOutcomes': [{'measure': 'To elicit opinions from patients who have previously undergone BRCA1/2 genetic counseling as to when and how information about PGD/PND should be presented (e.g., timing, level of detail,etc)', 'timeFrame': 'conclusion of study'}, {'measure': 'To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected).', 'timeFrame': 'conclusion of study'}, {'measure': 'To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers.', 'timeFrame': 'conclusion of study'}]}, 'conditionsModule': {'keywords': ['Breast', 'Ovary', 'Mutation carrier'], 'conditions': ['Breast Cancer', 'Ovarian Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "We are inviting you to participate in a study of how people who have had genetic counseling for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of passing increased risk onto one's children. We would also like feedback from patients who have been to our clinic in the past on the best ways to talk about PGD and PND during genetic counseling sessions. We are seeking both the opinions of people who are interested in these technologies and those who are not. It does not matter whether you have heard of PGD or PND before - you can still participate. Your past experience with genetic counseling is valuable to us in deciding how to communicate this information during sessions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective participants will be recruited through the MSKCC clinics that serve high-risk patients (e.g. Clinical Genetics Service, Special Surveillance Breast Program, etc.)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females and males who are carriers of deleterious mutations in the genes BRCA1 or BRCA2.\n* Over age 18 and:\n\n 1. For women, less than 43\n 2. For men, less than 50.\n* Received genetic testing and counseling for BRCA.\n* Fluent in English.\n\nExclusion Criteria:\n\n* Patients who are currently under treatment (chemotherapy, radiation)\n* Individuals who refuse to discuss reproductive issues.\n* Unable to give informed consent due to physical, cognitive, or psychiatric disability'}, 'identificationModule': {'nctId': 'NCT00735150', 'briefTitle': 'Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk', 'orgStudyIdInfo': {'id': '06-137'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '25 female and 5 male BRCA carriers', 'interventionNames': ['Behavioral: questionnaire, interview']}], 'interventions': [{'name': 'questionnaire, interview', 'type': 'BEHAVIORAL', 'description': 'You will be asked to make a one-time visit to MSKCC. At that research visit, you will be asked to complete a short questionnaire about your knowledge of various reproductive technologies relevant to individuals at hereditary risk. Then you will watch a short presentation about these reproductive technologies and complete a second brief questionnaire to assess your understanding of the presentation. Afterwards, you will meet with an interviewer one-on-one for about one hour, during which time you may share your thoughts and feelings about the use of these reproductive technologies.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Karen Hurley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The New School for Social Research', 'class': 'OTHER'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'New York Presbyterian Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Karen Hurley, PhD', 'oldOrganization': 'Memorial Sloan-Kettering Cancer Center'}}}}