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Screening Study of Surgery and CA 125 Levels in Participants at Increased Genetic Risk of Ovarian Cancer

2014-07-24 14:33:57 | BioPortfolio

Summary

RATIONALE: Surgery to remove the fallopian tubes and ovaries may decrease the risk of ovarian cancer and may improve quality of life in women who are at increased genetic risk. Monitoring CA 125 levels may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.

PURPOSE: Screening trial to study the effectiveness of surgery to remove the fallopian tubes and ovaries combined with monitoring of CA 125 levels in participants who are at increased genetic risk for ovarian cancer.

Description

OBJECTIVES:

Primary

- Compare the prospective incidence of ovarian cancer, breast cancer, fallopian tube cancer, primary peritoneal cancer, and all cancer in participants at increased genetic risk of ovarian cancer who undergo risk-reducing salpingo-oophorectomy (RRSO) or CA 125 screening.

- Determine the prevalence of clinically occult ovarian cancer and fallopian tube cancer and precursor lesions in participants who undergo RRSO.

- Determine the positive predictive value and specificity of the Risk of Ovarian Cancer Algorithm (ROCA) based on serial CA 125 measurements for ovarian cancer in participants who do not undergo RRSO.

- Compare quality of life, sexual functioning, frequency of menopausal symptoms, depression, anxiety, cancer worry, and concerns associated with familial risk of ovarian cancer in participants who undergo RRSO vs screening.

- Compare changes in these quality of life parameters over time in these participants.

- Establish a longitudinal serum, plasma, and tissue repository for the evaluation of promising biomarkers and genetic alterations with relevance to familial ovarian and breast cancer risk.

Secondary

- Determine patterns of use of medications (e.g., tamoxifen, raloxifene, estrogen or hormonal replacement therapy, alendronate, or vaginal estrogens) that may alter the risk of important medical outcomes (e.g., cancer endpoints or estrogen deficiency disorders) in these participants.

- Monitor overall mortality and the incidence of various disease states that complicate long-term estrogen deficiency (e.g., osteoporosis, skeletal fractures, coronary artery disease, or myocardial infarction) in these participants.

- Monitor these participants' and their health care providers' adherence to recommendations regarding the management of non-oncologic morbidity related to premature menopause.

- Analyze the factors (regarding cancer risk reduction and screening activities) that influence a woman's choice between RRSO vs screening.

- Establish normal ranges and distributions within and between high-risk participants for CA 125 values over time, with sub-classification by pre/postmenopausal status, HRT usage, RRSO status, and other risk factors.

OUTLINE: This is a multicenter study. Participants choose 1 of 2 screening/prevention groups.

- Group I (screening): Participants undergo genetic risk, medical and ovarian cancer risk factor; transvaginal ultrasound (TVUS); and CA 125 measurement. CA 125 is measured every 3 months and the Risk of Ovarian Cancer Algorithm (ROCA) is determined.TVUS is repeated annually (unless ovaries have been removed) as is a mammogram. If screening tests are abnormal, TVUS may be repeated and laparotomy/laparoscopy may be performed if a malignancy is suspected or a benign finding requires surgery.

- Group II (risk-reducing surgery): Participants undergo genetic risk, medical and ovarian cancer risk factor; TVUS; and CA 125 measurement. Participants then undergo risk-reducing salpingo-oophorectomy (RRSO). CA 125 is measured and ROCA calculated every 6 months. A mammogram is performed annually. Abnormal screening results are treated as in group I.

Quality of life is assessed at baseline and at 6, 12, 24, and 60 months for some participants.

Participants in group I who decide to undergo RRSO may cross-over to group II at any time.

PROJECTED ACCRUAL: A total of 2,332 participants will be accrued for this study.

Study Design

Allocation: Non-Randomized, Control: Active Control, Primary Purpose: Screening

Conditions

Ovarian Cancer

Intervention

cancer prevention, physiologic testing, screening questionnaire administration, annual screening, comparison of screening methods, conventional surgery, evaluation of cancer risk factors, long-term screening, study of high risk factors

Location

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham
Alabama
United States
35294

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:33:57-0400

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