Microsoft word - rossing_ovcare 4_1_10.doc

PHS Biorepository Form
The OVCARE Study (Fertility Drug Use and Ovarian Cancer) Our goal was to examine the relation of infertility and its treatment with risk of ovarian cancer. Specifically, we conducted this case-control study to investigate whether clomiphene citrate or other ovulation-inducing drugs used as fertility treatment may increase the risk of ovarian cancer. A secondary goal of the study was to collect blood samples to serve as a resource for future assessment of the impact of inherited genetic susceptibility to ovarian cancer in a population-based study of relatively young women. In addition, interview data provided information on possible confounders or effect modifiers of the relationship between fertility drug use and ovarian cancer and allowed us to examine other secondary hypotheses. This multi-center population based, case-control study was carried out by the Fred Hutchinson Cancer Research Center between April 1, 1996 and March 31, 2001. Women from the Seattle, Washington area (King County), the Detroit, Michigan area (Wayne, Oakland and Macomb Counties), and the Atlanta, Georgia area ( Fulton, Cobb, and Dekalb Counties) were eligible. The study included women with borderline ovarian tumors diagnosed during the time period July 1, 1994 through April 30, 1998 or with invasive ovarian tumors diagnosed from July 1, 1995 through June 30, 1998. Controls for the study were identified and interviewed through the CARE study. 2001 (yyyy) For ongoing studies, enter estimated end date. 8. Total number of participants enrolled to date: Seattle: 118 cases, Detroit: 202 cases, and Atlanta: 70 cases. The controls were identified and interviewed through the CARE study and therefore are not part of the OVCARE Biorepository. Version 01 Final: 02-09-10
PHS Biorepository Form 1
PHS Biorepository Form
9. Enter information about study populations enrolled and endpoints collected, as applicable. 9a. For cohort, non-cohort prospective, randomized, non-randomized, cross-sectional, and other, specify: 9b. For case-control and nested case-control: Version 01 Final: 02-09-10
PHS Biorepository Form 2
PHS Biorepository Form
Women diagnosed with invasive ovarian tumors between July 1995 and June 1998, and borderline tumors between July 1994 and April 1998. Women were aged 35-54 at diagnosis, and residents of the Seattle area, Detroit area, or Atlanta area. * CARE controls who were residents of the Seattle, Atlanta, or Detroit areas, aged 35-54 years at reference date. *Comments: The controls for this study were interviewed through the CARE study. 10. Provide approximate numbers or percents of ethnicities represented in the study: 2.7% n / % Hispanic 11. Provide approximate numbers or percents of all races represented in the study: Only White and Black
Women were eligible for this study.

86.0% n / % White
0.0% n / % American Indian/Alaska Native 0.0% n / % Native Hawaiian/Pacific Islander 12. Age range of participants: 35 Minimum age 13. Participant gender(s): 100% n / % Female 15. Data collection timeframe: mm/dd/yyyy Start 16. Select all types of data collected: Version 01 Final: 02-09-10
PHS Biorepository Form 3
PHS Biorepository Form
17. Select all data collection methods: Data collection comments: Cases were ascertained through the regional SEER cancer registries. Willing cases were interviewed in person by a trained interviewer/phlebotomist using a standardized questionnaire. 18. Select all types of specimens collected: 19. Does the study have IRB approval as a “bio-repository?” (This allows the collection, storage, or distribution of data, biological specimens, or medical records for research purposes other than those described for this specific study.) 20. Is there a possibility that the specimens could be made available for use by another study? Version 01 Final: 02-09-10
PHS Biorepository Form 4
PHS Biorepository Form
21. Enter specific information about specimens in the study repository. Detroit (all ACD) and 111 from Seattle ( EDTA and ACD) Version 01 Final: 02-09-10
PHS Biorepository Form 5
PHS Biorepository Form
22. Information on individuals who should be contacted regarding follow-up questions to this survey. Name 23. Data storage location (what institution, division, server, etc., stores the data?): FHCRC IT Server 24. Data storage application (e.g., SAS, SQL, Excel): Primarily SQL, but also STATA, SAS, SPSS, Access, ASCII, and Excel 25. Are the data web accessible? 26. Select all methods for retrieving data: Version 01 Final: 02-09-10
PHS Biorepository Form 6


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