Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT00322894
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2006-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Breast Cancer Registry and Tissue Repository
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sample of tumor, buccal cells and blood collected at the time of study enrollment.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2006-05-05', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess clinico-pathologiv variables and outcomes', 'timeFrame': '10 years', 'description': 'Utilize the Extended Breast Cancer Repository clinical database to determine the relationship between clinico-pathologic variables and patient outcomes.'}], 'primaryOutcomes': [{'measure': 'Identify risk factors for breast cancer', 'timeFrame': '4 years', 'description': 'Prospectively collect demographic, risk factor, diagnosis and treatment data and tissues (blood, buccal cells and tumor if appicable) for breast cancer patients seen at the UNM Cancer Center to assist in identification of unique factors that may impact patient prognosis in this population.'}], 'secondaryOutcomes': [{'measure': 'Establish a centralized tissue repository', 'timeFrame': '4 years', 'description': 'Establish a centralized tissue repository (breast and related tissues) to serve as a resource for current and future scientific studies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Risk factors', 'Treatment', 'Clinico-pathologic', 'Outcomes', 'Tissue repository', 'Registry'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cancer.unm.edu', 'label': 'University of New Mexico Cancer Center'}, {'url': 'http://www.nmcca.org', 'label': 'New Mexico Cancer Care Alliance'}]}, 'descriptionModule': {'briefSummary': 'The Expanded Breast Cancer Registry and Tissue Repository Research Team (EBCR-RT) is comprised of University of Mexico Comprehensive Cancer Center faculty and staff whose goals are to improve the outcomes and quality of life of patients with breast cancer, and ultimately to eradicate and cure breast cancer. One focus of the EBCR-RT is the creation an infrastructure that can potentially be adopted as a model for a statewide registry and tissue repository for the discovery of biomarkers for this disease.\n\nThe goals of the EBCR are:\n\n1. To register patients diagnosed with breast cancer and information relevant to their diagnosis (such as stage, grade, hormone receptor status, etc), treatment (surgery, radiation, chemotherapy, hormone therapy, etc), and survivorship (Quallity of Life, etc).\n2. To collect relevant demographics including age, menopausal status, race/ethnicity, body mass index (BMI), place of residence, behaviors (smoking, alcohol intake, etc)\n3. To establish a paired tumor tissue and blood sample for each relevant time-point (as defined in the protocol), which will be stored in the Tissue Bank Shared Resource Facility for future hypothesis-driven research.', 'detailedDescription': 'Institutions and/or physicians are required to report each new diagnosis of breast cancer to the New Mexico Tumor Registry (NMTR). The NMTR is a valuable database that provides information on breast cancer, including trends in incidence and survival. However, relevant information on breast cancer prognosis and treatment is either not routinely collected or not readily available to the NMTR. We propose to establish an Expanded Breast Cancer Registry and Tissue Repository (EBCR) at this institution that could serve as an infrastructure for collection of this information. Furthermore, a tissue bank will be established for collection of paired tissue (tumor, buccal cells and blood sample) from patients diagnosed with breast cancer who consent to providing excess/extra tissue and additional blood for the Tissue Repository. This tissue bank will serve as a repository from which researchers can access tissue samples to conduct laboratory-based studies of genetic determinants of breast cancer risks, prognosis and survival in women with breast cancer seen in this institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with breast cancer during the study period commencing January 2006, regardless of gender, ethnicity/race, stage of disease or treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed with breast cancer, regardless of gender, ethnicity/race, stage of disease or treatment, are eligible.\n* Patients must be less than or equal to one year from diagnosis of non-metastatic breast cancer OR less than or equal to one year from initiation of treatment for metastatic disease.\n* Pathological diagnosis of breast cancer\n* Expected availability of clinical follow up data\n* Eighteen years old or older\n* Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines\n\nExclusion Criteria:\n\n* Not specified.'}, 'identificationModule': {'nctId': 'NCT00322894', 'briefTitle': 'Expanded Breast Cancer Registry and Tissue Repository', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico Cancer Research Alliance'}, 'officialTitle': 'Expanded Breast Cancer Registry and Tissue Repository', 'orgStudyIdInfo': {'id': 'INST 0552C'}}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Comprehensive Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Melanie Royce, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of New Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}