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Trial NCT00898586

Resource URI: http://static.linkedct.org/resource/trials/NCT00898586
linkedct:brief_title Study of Biomarkers in Samples in the NCI Breast Cancer Serum Bank Collected From Premenopausal Women With Benign Breast Disease
linkedct:condition <http://static.linkedct.org/resource/condition/1883>
linkedct:criteria DISEASE CHARACTERISTICS: - Premenopausal women meeting the following criteria: - Underwent breast biopsy at four hospitals in Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease - Had never been diagnosed with breast cancer at the time of initial benign breast biopsy (and within 60 days of the procedure) - At least 4 mL of serum stored in the NCI Frederick Cancer Research Center biorepository - Pathology report successfully retrieved from a participating hospital for review PATIENT CHARACTERISTICS: - Caucasian or African-American PRIOR CONCURRENT THERAPY: - See Disease Characteristics
linkedct:description OBJECTIVES: - To retrieve and code the initial pathology report pertaining to the benign breast disease biopsy from premenopausal women in the NCI serum bank. - To trace participants and link to statewide cancer registries and the National Death Index (NDI) to identify breast cancer cases. - To genotype participants who are found, after the retrieval and coding, to have benign breast disease diagnoses that confer a considerably elevated risk of breast cancer, or those who are found, after tracing, to have developed breast cancer during follow-up, and selected matched controls. OUTLINE: Participants' biopsy reports are obtained for review and recoding, and participants are traced for vital status and breast cancer development. Blood samples (stored in the NCI serum Bank) from women who has premalignant breast condition or found to have developed breast cancer after tracing are examined. Variants in genes related to hormone metabolism and cell signaling, processes implicated in the development of premalignant breast conditions, and in genes associated with cell cycle control and apoptosis are assessed at the NCI Central Genotyping Facility.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 15 Years
linkedct:enrollment 2636 (xsd:int)
linkedct:firstreceived_date May 9, 2009
linkedct:id NCT00898586
rdfs:label Trial NCT00898586
linkedct:lastchanged_date May 9, 2009
linkedct:lead_sponsor_agency National Cancer Institute (NCI)
linkedct:location <http://static.linkedct.org/resource/location/162427>
linkedct:nct_id NCT00898586
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Risk of Breast Cancer and Hyperplastic Conditions in the Breast Cancer Serum Bank in Relation to Inherited Genetic Variants
linkedct:org_study_id CDR0000573193
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/8117>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/3038>
foaf:page <http://clinicaltrials.gov/show/NCT00898586>
linkedct:phase N/A
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/10385>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/18605>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/4946>
linkedct:secondary_id NCI-05-C-N061
linkedct:source National Cancer Institute (NCI)
linkedct:start_date December 2004
linkedct:study_design N/A
linkedct:study_type Observational
linkedct:summary RATIONALE: Studying tissue and blood samples from women with benign breast disease in the laboratory may help doctors learn more about the risk for developing breast cancer. PURPOSE: This study is looking at biomarkers in samples in the NCI Breast Cancer Serum Bank from premenopausal women with benign breast disease.
rdf:type linkedct:trials
linkedct:verification_date April 2008