Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT00900367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-08-13
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}], 'ancestors': [{'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'we have only plasma, NHS has DNA samples.\n\nStudy is nested case control, so retrospective with respect to individual inclusion, prospective with respect to sample collected before disease. Enrollment is approximate as it includes samples that will be drpped, eg for QC resons'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-11', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generation of metabolome profiles that reflect nutritional status', 'timeFrame': 'ongoing'}, {'measure': 'Utility of rat metabolome profiles for human epidemiological studies', 'timeFrame': 'ongoing'}, {'measure': 'Utility of metabolome profiles in predicting relative risk of developing breast cancer', 'timeFrame': 'ongoing'}, {'measure': 'Identification of critical serum metabolites', 'timeFrame': 'ongoing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. It may also help doctors predict a woman's risk of developing breast cancer.\n\nPURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.", 'detailedDescription': 'OBJECTIVES:\n\n* To complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies.\n* To determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies.\n* To identify critical serum metabolites.\n\nOUTLINE: Laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women enrolled in the NHS I study; Group selected by Drs. Willett and Hankinson', 'healthyVolunteers': True, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case)\n\n * No prior diagnosis of cancer\n * Healthy participant (control)\n* Enrolled in the Nurses' Health Study\n* Banked blood samples available\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00900367', 'briefTitle': 'Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Nutrition Modulated Metabolism as a Disease Risk Factor', 'orgStudyIdInfo': {'id': 'CDR0000583255'}, 'secondaryIdInfos': [{'id': 'BWH-BRC322'}, {'id': 'R01CA102536', 'link': 'https://reporter.nih.gov/quickSearch/R01CA102536', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'high performance liquid chromatography', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'spectroscopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Dana-Farber/Brigham and Women's Cancer Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bruce S. Kristal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bruce Kristal', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}