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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


N/A
30 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


OBJECTIVES:

- 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 BRCA1/2 mutation
carriers.

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

- To compare the cancer rates between these two groups of women.

- To better characterize the similarities and differences in cancer risk between BRCA
mutation-positive families and BRCA mutation-negative/family history-positive families.

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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)

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer

Safety Issue:

No

Principal Investigator

Mark H. Greene, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Clinical Genetics Branch

Authority:

United States: Federal Government

Study ID:

CDR0000674216

NCT ID:

NCT01139957

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • ovarian neoplasm
  • fallopian tube cancer
  • breast cancer
  • primary peritoneal cavity cancer
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

National Naval Medical Center Bethesda, Maryland  20889
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Hurley Medical Center Flint, Michigan  48503
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Sarasota Memorial Hospital Sarasota, Florida  34239
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
Yale Cancer Center New Haven, Connecticut  06520-8028
NYU Cancer Institute at New York University Medical Center New York, New York  10016
St. Elizabeth Medical Center Edgewood, Kentucky  41017
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Maine Medical Center - Bramhall Campus Portland, Maine  04102
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Mecosta County Medical Center Big Rapids, Michigan  49307
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Evanston Hospital Evanston, Illinois  60201-1781
Greater Baltimore Medical Center Cancer Center Baltimore, Maryland  21204
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst, North Carolina  28374
Union Hospital of Cecil County Elkton MD, Maryland  21921
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Louisville Oncology at Norton Cancer Institute - Louisville Louisville, Kentucky  40202
Mercy General Health Partners Muskegon, Michigan  49443
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Tufts Medical Center Cancer Center Boston, Massachusetts  02111
New Ulm Medical Center New Ulm, Minnesota  56073
Women's Cancer Associates Saint Petersburg, Florida  33701
St. Vincent Oncology Center Indianapolis, Indiana  46260