Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01139957
Collaborator
National Cancer Institute (NCI) (NIH)
1,916
141
118.1
13.6
0.1

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
  • Procedure: Evaluation of Cancer Risk Factors
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Procedure: Study of High Risk Factors

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.

  3. 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.

  4. 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

Study Type:
Observational
Anticipated Enrollment :
1916 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants
Actual Study Start Date :
Jun 7, 2010
Actual Primary Completion Date :
Apr 10, 2020
Actual Study Completion Date :
Apr 10, 2020

Arms and Interventions

Arm Intervention/Treatment
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:
  • cancer risk factors evaluation
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Procedure: Study of High Risk Factors
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer [Up to 5 years]

    2. 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.

    3. Breast cancer mortality rates [Up to 5 years]

    4. Quality of life [Up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Enrolled on GOG-0199

    • Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer

    • Completed the Off-Study form (Form Q0-0199 submitted via SEDES)

    • 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
    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.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01139957
    Other Study ID Numbers:
    • GOG-8199
    • NCI-2011-02233
    • CDR0000674216
    • GOG-8199
    • GOG-8199
    • GOG-8199
    • U10CA101165
    First Posted:
    Jun 9, 2010
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 2, 2020