Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
Study Details
Study Description
Brief Summary
This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
PRIMARY OBJECTIVES:
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To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (BRCA)1/2 mutation carriers.
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To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.
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To compare the cancer rates between these two groups of women. IV. To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.
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To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).
OUTLINE: This is a multicenter study.
Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Ancillary-correlative Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer. |
Procedure: Evaluation of Cancer Risk Factors
Ancillary studies
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
Procedure: Study of High Risk Factors
Ancillary studies
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Outcome Measures
Primary Outcome Measures
- Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer [Up to 5 years]
- Ovarian cancer mortality rates [Up to 5 years]
Cox proportional hazards models will be used to compare the incidence rates between the risk-reducing salpingo-oophorectomy (RRSO) and screening groups, adjusting for appropriate covariates. If necessary, modeling will be carried out in order to use non-proportional hazards models.
- Breast cancer mortality rates [Up to 5 years]
- Quality of life [Up to 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Enrolled on GOG-0199
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Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
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Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
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No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
2 | Gynecologic Oncology Group of Arizona | Phoenix | Arizona | United States | 85012 |
3 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
4 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
5 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
6 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
7 | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | United States | 06105 |
8 | The Hospital of Central Connecticut | New Britain | Connecticut | United States | 06050 |
9 | Yale University | New Haven | Connecticut | United States | 06520 |
10 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
11 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
12 | Florida Gynecologic Oncology | Fort Myers | Florida | United States | 33905 |
13 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
14 | Women's Cancer Associates | Saint Petersburg | Florida | United States | 33701 |
15 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
16 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859 |
17 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
18 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
19 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
20 | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | United States | 60201 |
21 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
22 | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
23 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
24 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
25 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
26 | Saint Luke's South Hospital | Overland Park | Kansas | United States | 66213 |
27 | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas | United States | 66208 |
28 | Saint Elizabeth Medical Center South | Edgewood | Kentucky | United States | 41017 |
29 | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky | United States | 40202 |
30 | Maine Medical Center-Bramhall Campus | Portland | Maine | United States | 04102 |
31 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
32 | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | United States | 21237 |
33 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
34 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
35 | Union Hospital of Cecil County | Elkton | Maryland | United States | 21921 |
36 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
37 | UMass Memorial Medical Center - Memorial Division | Worcester | Massachusetts | United States | 01605 |
38 | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | United States | 48106 |
39 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
40 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
41 | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | United States | 49307 |
42 | Beaumont Hospital - Dearborn | Dearborn | Michigan | United States | 48124 |
43 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
44 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
45 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
46 | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | United States | 48532 |
47 | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | United States | 49503 |
48 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
49 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
50 | Allegiance Health | Jackson | Michigan | United States | 49201 |
51 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
52 | Saint Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
53 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
54 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
55 | Lake Huron Medical Center | Port Huron | Michigan | United States | 48060 |
56 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
57 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
58 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
59 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
60 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
61 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
62 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
63 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
64 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
65 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
66 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
67 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
68 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
69 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
70 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
71 | New Ulm Medical Center | New Ulm | Minnesota | United States | 56073 |
72 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
73 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
74 | Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | United States | 55416 |
75 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
76 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
77 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
78 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
79 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
80 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
81 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
82 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
83 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
84 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
85 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
86 | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri | United States | 64118 |
87 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
88 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
89 | Liberty Radiation Oncology Center | Liberty | Missouri | United States | 64068 |
90 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
91 | Saint Joseph Oncology Inc | Saint Joseph | Missouri | United States | 64507 |
92 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
93 | Nebraska Cancer Research Center | Lincoln | Nebraska | United States | 68510 |
94 | Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
95 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
96 | Alegent Health Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
97 | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
98 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
99 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
100 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
101 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
102 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
103 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
104 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
105 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
106 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
107 | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | United States | 28374 |
108 | Aultman Health Foundation | Canton | Ohio | United States | 44710 |
109 | University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio | United States | 45219 |
110 | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio | United States | 45220 |
111 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
112 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
113 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
114 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
115 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
116 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
117 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
118 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
119 | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | United States | 74146 |
120 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
121 | Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301 |
122 | Lankenau Medical Center | Wynnewood | Pennsylvania | United States | 19096 |
123 | Main Line Health NCORP | Wynnewood | Pennsylvania | United States | 19096 |
124 | Women and Infants Hospital | Providence | Rhode Island | United States | 02905 |
125 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
126 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
127 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
128 | Wilford Hall Medical Center | Lackland Air Force Base | Texas | United States | 78236 |
129 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
130 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
131 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
132 | Carilion Clinic Gynecological Oncology | Roanoke | Virginia | United States | 24016 |
133 | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | United States | 54729 |
134 | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | United States | 54701 |
135 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
136 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
137 | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | United States | 54548 |
138 | Ascension Saint Mary's Hospital | Rhinelander | Wisconsin | United States | 54501 |
139 | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | United States | 54868 |
140 | Marshfield Clinic - Weston Center | Weston | Wisconsin | United States | 54476 |
141 | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
Sponsors and Collaborators
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Mark H Greene, Gynecologic Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GOG-8199
- NCI-2011-02233
- CDR0000674216
- GOG-8199
- GOG-8199
- GOG-8199
- U10CA101165