BACKGROUND: Women who are genetically predisposed to ovarian cancer are at very high risk of developing this disease. Although risk-reducing salpingo-oophorectomy (RRSO) and various screening regimens are currently recommended to reduce ovarian cancer risk, the optimal management strategy has not been established nor have multiple additional issues been adequately addressed. We developed a collaboration among the Clinical Genetics Branch (National Cancer Institute's Intramural Research Program), the Gynecologic Oncology Group (GOG), and the Cancer Genetics Network to address these issues. METHODS: This is a prospective, international, two-cohort, nonrandomized study of women at genetic risk of ovarian cancer, who chose either to undergo RRSO or screening, at study enrollment. Primary study objectives include quantifying and comparing ovarian and breast cancer incidence in the two study groups, assessing feasibility and selected performance characteristics of a novel ovarian cancer screening strategy (the Risk of Ovarian Cancer Algorithm), evaluating various aspects of quality of life and nononcologic morbidity related to various interventions in at-risk women, and creating a biospecimen repository for subsequent translational research. RESULTS: Study accrual is complete as of November 2006; 2,605 participants enrolled: 1,030 (40%) into the surgical cohort and 1,575 (60%) into the screening cohort. Five years of prospective follow-up ends in November 2011. Verification of BRCA mutation carrier status is under way, either through patient-provided reports from clinical genetic testing done before enrollment or through research-based genetic testing being conducted as part of the protocol. Patient eligibility is currently under evaluation and baseline, surgical, pathology, and outcome data are still being collected. The study design and selected baseline characteristics of cohort members are summarized. CONCLUSION: This National Cancer Institute intramural/extramural collaboration will provide invaluable prospectively collected observational data on women at high familial ovarian cancer risk, including substantial numbers of women carrying BRCA1/2 mutations. These data will aid in elucidating the effect of RRSO on breast/ovarian cancer risk and the effects of two management strategies, on quality of life and other issues that may influence patient care, as well as providing preliminary estimates of test specificity and positive predictive value of a novel ovarian cancer screening strategy.
BACKGROUND:Women who are genetically predisposed to ovarian cancer are at very high risk of developing this disease. Although risk-reducing salpingo-oophorectomy (RRSO) and various screening regimens are currently recommended to reduce ovarian cancer risk, the optimal management strategy has not been established nor have multiple additional issues been adequately addressed. We developed a collaboration among the Clinical Genetics Branch (National Cancer Institute's Intramural Research Program), the Gynecologic Oncology Group (GOG), and the Cancer Genetics Network to address these issues. METHODS: This is a prospective, international, two-cohort, nonrandomized study of women at genetic risk of ovarian cancer, who chose either to undergo RRSO or screening, at study enrollment. Primary study objectives include quantifying and comparing ovarian and breast cancer incidence in the two study groups, assessing feasibility and selected performance characteristics of a novel ovarian cancer screening strategy (the Risk of Ovarian Cancer Algorithm), evaluating various aspects of quality of life and nononcologic morbidity related to various interventions in at-risk women, and creating a biospecimen repository for subsequent translational research. RESULTS: Study accrual is complete as of November 2006; 2,605 participants enrolled: 1,030 (40%) into the surgical cohort and 1,575 (60%) into the screening cohort. Five years of prospective follow-up ends in November 2011. Verification of BRCA mutation carrier status is under way, either through patient-provided reports from clinical genetic testing done before enrollment or through research-based genetic testing being conducted as part of the protocol. Patient eligibility is currently under evaluation and baseline, surgical, pathology, and outcome data are still being collected. The study design and selected baseline characteristics of cohort members are summarized. CONCLUSION: This National Cancer Institute intramural/extramural collaboration will provide invaluable prospectively collected observational data on women at high familial ovarian cancer risk, including substantial numbers of women carrying BRCA1/2 mutations. These data will aid in elucidating the effect of RRSO on breast/ovarian cancer risk and the effects of two management strategies, on quality of life and other issues that may influence patient care, as well as providing preliminary estimates of test specificity and positive predictive value of a novel ovarian cancer screening strategy.
Authors: Diane Stirling; D Gareth R Evans; Gabriella Pichert; Andrew Shenton; Elaine N Kirk; Sylvia Rimmer; C Michael Steel; Sheila Lawson; R M Camille Busby-Earle; Jane Walker; Fiona I Lalloo; Diana M Eccles; Anneke M Lucassen; Mary E Porteous Journal: J Clin Oncol Date: 2005-08-20 Impact factor: 44.544
Authors: Robert W Haile; Duncan C Thomas; Valerie McGuire; Anna Felberg; Esther M John; Roger L Milne; John L Hopper; Mark A Jenkins; A Joan Levine; Mary M Daly; Saundra S Buys; Ruby T Senie; Irene L Andrulis; Julia A Knight; Andrew K Godwin; Melissa Southey; Margaret R E McCredie; Graham G Giles; Lesley Andrews; Katherine Tucker; Alexander Miron; Carmel Apicella; Andrea Tesoriero; Anita Bane; Malcolm C Pike; Alice S Whittemore Journal: Cancer Epidemiol Biomarkers Prev Date: 2006-10-04 Impact factor: 4.254
Authors: B Y Karlan; R L Baldwin; E Lopez-Luevanos; L J Raffel; D Barbuto; S Narod; L D Platt Journal: Am J Obstet Gynecol Date: 1999-04 Impact factor: 8.661
Authors: M Aarnio; R Sankila; E Pukkala; R Salovaara; L A Aaltonen; A de la Chapelle; P Peltomäki; J P Mecklin; H J Järvinen Journal: Int J Cancer Date: 1999-04-12 Impact factor: 7.396
Authors: Roger L Milne; Julia A Knight; Esther M John; Gillian S Dite; Ronald Balbuena; Argyrios Ziogas; Irene L Andrulis; Dee W West; Frederick P Li; Melissa C Southey; Graham G Giles; Margaret R E McCredie; John L Hopper; Alice S Whittemore Journal: Cancer Epidemiol Biomarkers Prev Date: 2005-02 Impact factor: 4.254
Authors: Susan M Domchek; Tara M Friebel; Susan L Neuhausen; Theresa Wagner; Gareth Evans; Claudine Isaacs; Judy E Garber; Mary B Daly; Rosalind Eeles; Ellen Matloff; Gail E Tomlinson; Laura Van't Veer; Henry T Lynch; Olufunmilayo I Olopade; Barbara L Weber; Timothy R Rebbeck Journal: Lancet Oncol Date: 2006-03 Impact factor: 41.316
Authors: A S Whittemore; R R Balise; P D P Pharoah; R A Dicioccio; I Oakley-Girvan; S J Ramus; M Daly; M B Usinowicz; K Garlinghouse-Jones; B A J Ponder; S Buys; R Senie; I Andrulis; E John; J L Hopper; M S Piver Journal: Br J Cancer Date: 2004-11-29 Impact factor: 7.640
Authors: Steven J Skates; Mark H Greene; Saundra S Buys; Phuong L Mai; Powel Brown; Marion Piedmonte; Gustavo Rodriguez; John O Schorge; Mark Sherman; Mary B Daly; Thomas Rutherford; Wendy R Brewster; David M O'Malley; Edward Partridge; John Boggess; Charles W Drescher; Claudine Isaacs; Andrew Berchuck; Susan Domchek; Susan A Davidson; Robert Edwards; Steven A Elg; Katie Wakeley; Kelly-Anne Phillips; Deborah Armstrong; Ira Horowitz; Carol J Fabian; Joan Walker; Patrick M Sluss; William Welch; Lori Minasian; Nora K Horick; Carol H Kasten; Susan Nayfield; David Alberts; Dianne M Finkelstein; Karen H Lu Journal: Clin Cancer Res Date: 2017-01-31 Impact factor: 12.531
Authors: Phuong L Mai; Marion Piedmonte; Paul K Han; Richard P Moser; Joan L Walker; Gustavo Rodriguez; John Boggess; Thomas J Rutherford; Oliver Zivanovic; David E Cohn; J Tate Thigpen; Robert M Wenham; Michael L Friedlander; Chad A Hamilton; Jamie Bakkum-Gamez; Alexander B Olawaiye; Martee L Hensley; Mark H Greene; Helen Q Huang; Lari Wenzel Journal: Gynecol Oncol Date: 2017-02-10 Impact factor: 5.482
Authors: Hannah P Yang; William F Anderson; Philip S Rosenberg; Britton Trabert; Gretchen L Gierach; Nicolas Wentzensen; Kathleen A Cronin; Mark E Sherman Journal: J Clin Oncol Date: 2013-05-06 Impact factor: 44.544