Removal of the Ovaries/Fallopian Tubes and CA-125 Screening to Reduce the Risk of Ovarian Cancer in Women at Increased Genetic Risk
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|ClinicalTrials.gov Identifier: NCT00043472|
Recruitment Status : Completed
First Posted : August 9, 2002
Last Update Posted : October 26, 2021
This study will evaluate women who are at increased genetic risk of developing ovarian cancer because they or a close relative have a mutation in the BRCA1 or BRCA2 gene (the genes that cause most of the genetic forms of ovarian cancer) or because they have a very strong family history of breast and/or ovarian cancer. The study has two aspects. There will be two groups of subjects in this study. One group of women who will have their ovaries and fallopian tubes surgically removed as a prophylactic (preventive) measure against developing ovarian/fallopian tube cancer. These women will be studied to determine whether the surgery does, in fact, decrease the risk of ovarian or tubal cancer and whether it decreases the risk of breast and other cancers. The tissue removed at surgery will also be investigated to see whether a new way of examining the ovaries after they are removed provides better information about cancer-related tissue changes. A second group of subjects will be women who choose not to have preventive surgery. These women will be followed closely to see if screening with multiple CA-125 blood testing over time (see below) can detect ovarian or tubal cancers in their early stages. Both groups of women will undergo examination of the process by which women decide upon various options for lowering their ovarian cancer risk and a detailed assessment of how their choice impacts their quality of life. It will look at how those who opt for ovariectomy feel after their surgery and how those who choose screening feel during the time of screening.
All participants will undergo the following procedures:
- Medical history, physical examination, and blood drawing upon entering the study, including blood samples for future ovarian cancer research.
- Screening mammogram, CA-125 blood test, and transvaginal ultrasound upon entering the study, with yearly repeat mammograms for all participants and yearly transvaginal ultrasound exams for women in the screening arm of the study. CA-125 is a protein found in the blood whose levels are elevated in most women with ovarian cancer. Transvaginal ultrasound is a way of taking pictures of the ovaries using sound waves. If the results of these tests are not normal, additional tests may be required to learn the reason for the abnormality.
- Questionnaires about personal, medical and family history, ovarian cancer risk factors, medication use, medical choices, and quality of life on entering the study, with repeat quality of life and medication use questionnaires every 6 months during the study period.
- Blood samples for follow-up visits and for CA-125 testing every 3 months as a screen for ovarian/fallopian tube cancers. Some blood from these samples will be saved for future ovarian cancer research.
- Semi-annual report during the duration of the study regarding health and quality of life changes that occur over the prior 6-month period.
Researchers will use the pattern and rate of change of CA-125 levels over time in women in the screening group to decide if more tests are needed to test for ovarian cancer. Women in the surgery portion will undergo surgical removal of their ovaries and fallopian tubes. The removed tissues will be studied using new methods to examine the cells more closely than usual, and a portion of the tissues will be stored for future research on ovarian cancer. This study is being conducted in collaboration with the Gynecologic Oncology Group (GOG), and is designated GOG Protocol 0199. Subjects may join the study at any participating GOG institution (http://www.gog.org).
|Condition or disease|
|Breast Cancer Ovarian Cancer|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Prospective Study of Prophylactic Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer|
|Actual Study Start Date :||July 9, 2003|
Eligible women at least one intact ovary who have signed written, informed consent that they will undergo screening as per protocol.
Eligible women with at least one intact ovary who have signed written, informed consent that they will undergo risk reducing surgery
- To determine the prospective incidence of ovarian cancer, breastcancer, primary peritoneal carcinoma, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on womenwho are known BRCA1/2 mutation carriers [ Time Frame: Analysis complete ]1. Greene MH, et al.: A prospective study of riskreducing salpingooophorectomy and longitudinal CA-125 screening among women at increased genetic risk of ovarian cancer: design andbaseline characteristics: Cancer Epidemiol Biomarkers Prev 2008; 17:594-604 2. Mai PL, . Greene MH, Piedmonte M, Walker JL. Prospective risk of breast and ovarian cancer in GOG-0199 participants undergoing RRSO versus ROCA screening. Manuscript submitted (J Natl Cancer Inst)
- To assess prospectively the prevalence of clinically occult ovarian cancer and fallopian tube cancer among women undergoingprophylactic salpingooophorectomy, and to seek evidence of precursor lesions in the excised ovaries and fallopian tubes... [ Time Frame: Analysis Complete. ]1. Sherman ME*, Piedmonte M*, Mai PL* .Greene MH, et al. Pathologic Findings in Risk-Reducing Salpingo-Oophorectomy (RRSO):Primary Results from Gynecologic Oncology Group Trial GOG-0199. J Clin Oncol 2014; 32(29):3275-83 2. Bremer RC, Sherman ME, Ioffe OB, Ronnett BM, Piedmonte M, Greene MH, Mai PL. Fallopian tubalepithelial atypia findings and reproducibility in high risk women. Manuscript submitted (Int J Gyn Pathol)
- To quantify the positive predictive value and specificity of the Risk of Ovarian Cancer Algorithm (ROCA) based on serial CA-125 measurements for ovarian cancer in women who have elected not to undergo RRSO. [ Time Frame: Analysis Complete. ]Skates SJ, Greene MH, et al.: Early Detection of Ovarian Cancer using the Risk of Ovarian Cancer Algorithm with Frequent CA125 Testing in Women at Increased Familial Risk Combined Results from TwoScreening Trials. Clin Cancer Res 2017; 23(14):3628-3637
- To assess baseline and prospective quality of life andmedical decision-making as a function of various management strategies among study participants. [ Time Frame: Analysis Complete. ]1. Mai PL, . Greene MH, Hensley ML: Prospective follow-up of quality of life for participants undergoing riskreducing salpingooophorectomyor ovarian cancer screening in GOG- 0199: An NRG Oncology/GOGstudy. Manuscript submitted (Gynecologic Oncology)2. Mai PL, . Greene MH, Huang HQ, Wenzel L. Factors associated with deciding between risk-reducing salpingo-oophorectomy andovarian cancer screening among high-risk women in GOG-0199: An NRG Oncology /GOG Study. Gynecologic Oncology 2017; 145(1):122-129
- Establish a longitudinal serum, plasma and tissue repository for retrospective evaluation of other promising biomarkers and geneticalterations with special relevance to familial (genetic or otherwise) ovarian and breast cancer risk. [ Time Frame: Task Complete. Materialsavailable for ongoingtranslational research studies ]The GOG-0199 repository, maintained at the NRG/GOG Tissue Bank in Columbus OH contains: frozen whole blood, extracted DNA, sequential serum and plasma samples (q 3 mos in ROCA arm; q 6mos in RRSO arm), snapfrozen ovarian (L,R) and fallopian tube (L,R) tissue, peritoneal lavage samples, ascites, snap-frozen tumor tissue. Specimens used for (to date):-Serial CA-125 measurements (ROCA)-GWAS genotyping-MLPA assays for BRCA deletions, CNV-Central pathology review-Hormone assays pre-, post-RRSO
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043472
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Sharon A Savage, M.D.||National Cancer Institute (NCI)|