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Grant Details

Grant Number: 5R01CA081393-05 Interpret this number
Primary Investigator: Claus, Elizabeth
Organization: Yale University
Project Title: Long Term Outcomes for Women with Breast CA in Situ
Fiscal Year: 2004


DESCRIPTION (Adapted from the Applicant's Abstract): This project proposes to study the long-term health and lifestyle outcomes for study participants of a population-based case/control study of female breast carcinoma in-situ (BCIS). The study population includes all cases of female BCIS diagnosed among residents of the state of Connecticut from September 15, 1994 to March 14, 1998 as well as a series of random-digit-dial controls also selected from the state of Connecticut. Cases will be between the ages of 20 and 84 years at time of diagnosis while controls are frequency matched to the cases by five-year intervals. Current response rates indicate that the final sample will include approximately 1200 cases and 1200 controls. Baseline telephone interviews have already been conducted with the study subjects and include information on family history of cancer, pregnancy and menstrual history, hormone replacement therapy, oral contraceptive use, as well as socio-demographic variables. In addition, paraffin-embedded tumor tissue is being collected for each case to test for the presence of estrogen (ER), progesterone (PR), p53, and HER-2/neu using immunohistochemistry. The current application proposes to recontact study participants at five years from time of initial diagnosis/initial contact. Study subjects will again be asked to participate in a telephone interview to collect updated information on selected topic areas covered in the initial questionnaire such as medical history (breast recurrences, second cancers), family history, pregnancy and menstrual history but also to collect new information on selected measures of well-being and functioning including depression, career, sexual relations, and insurance. In addition, we will ask women to provide us with buccal specimens for BRCA1/BRCA2 testing. The goals of the study are as follows: 1) To provide annual and five-year cumulative estimates of ipsilateral and contralateral breast cancer risk, regional or distant metastatic disease risk, second cancer risk as well as death for women diagnosed with BCIS. 2) To assess the psychosocial impact of BCIS by examining differences between cases and controls on selected measures of well-being and functioning at five years after original recruitment. 3) To measure the association between clinical variables such as hormone receptor positivity and comedo necrosis on outcome for case subjects. 4) To assess the association between epidemiologic risk factors such as age and a family history of breast cancer with outcome, 5) To provide population-based estimates of BRCA1 and BRCA2 in BCIS. 6) To validate/evaluate current histopathologic classification schemes for BCIS with respect to clinical outcome. This project represents one of the first large attempts to assess the survivorship experience of women with BCIS. The data are unique in that epidemiologic, biologic and clinical variables will have been collected allowing us to study the relationship of these variables with long term outcome.



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