Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-28 @ 9:41 AM
Study NCT ID:
NCT00918892
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Candidate Protein Expression in Breast Cancer Specimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative 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': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differential expression of candidate genes between normal and cancer breast tissues', 'timeFrame': 'non-applicable', 'description': 'Approximately 5 slides of each tumor will be collected to provide sufficient samples for replicate staining, if necessary, as well as a staining for a positive control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'estrogen receptor-negative breast cancer', 'estrogen receptor-positive breast cancer', 'progesterone receptor-negative breast cancer', 'progesterone receptor-positive breast cancer', 'triple-negative breast cancer', 'HER2-negative breast cancer', 'HER2-positive breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/results?term=case1108', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.\n\nPURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine if candidate genes display differential expression between normal and cancer breast tissues.\n\nOUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDISEASE CHARACTERISTICS:\n\n* Diagnosis of breast cancer\n* Tissue samples available\n* Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:\n\n * Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative\n * ER-positive/PR-positive/ HER2-positive by FISH\n * ER-negative/PR-negative/HER2-positive\n * ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified\n\nExclusion Criteria:\n\n* There are no exclusion criteria in this protocol'}, 'identificationModule': {'nctId': 'NCT00918892', 'briefTitle': 'Assessment of Candidate Protein Expression in Breast Cancer Specimens', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Assessment of Candidate Protein Expression in Human Breast Cancer Specimens', 'orgStudyIdInfo': {'id': 'CASE1108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC', 'description': 'Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'description': 'Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Stefanie Avril, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}