Removal of the Ovaries/Fallopian Tubes and CA-125 Screening to Reduce the Risk of Ovarian Cancer in Women at Increased Genetic Risk

Eligible study participants were at least 30 years of age (no upper age limit), had at least one intact ovary, had no prior personal history of ovarian cancer, and were either documented carriers of deleterious germline mutations in BRCA1/BRCA2 or, if not tested, have greater than or equal to 20% estimated probability of being a mutation carrier, based on their family history. Enrollees chose between participating in a novel ovarian cancer screening study (using ROCA, the risk of ovarian cancer algorithm) or undergoing bilateral salpingo-oophorectomy. Extensive biospecimens and questionnaire data were collected, including a major behavioral/psychosocial component. All participants were followed prospectively for 5 years.

• INCLUSION CRITERIA:

To be considered at increased genetic risk of OC, subjects must have:

Age greater than or equal to 30;

No prior history of OC, including low malignant potential cancers (LMP), or primary papillary serous carcinoma of the peritoneum;

At least one intact ovary:

Satisfied one of the following additional criteria:

The family of the subject has a documented deleterious BRCA1 or BRCA2 mutation - either:

• the subject herself has tested positive for a deleterious BRCA1 or BRCA2 mutation; OR
• the subject has a first- or second-degree relative with a deleterious BRCA1 or BRCA2 mutation

OR

The family contains at least two ovarian and/or breast cancers among the subject or first- or second-degree relatives of the subject within the same lineage. This condition is satisfied by multiple primary cancers in the same person. Where breast cancer is required to meet this criterion, at least one breast cancer must have been diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown); OR

The subject is of Ashkenazi Jewish ethnicity with one first-degree or two second-degree relatives with breast and/or OC. Where breast cancer is required to meet this criterion, at least one case must have been diagnosed prior to menopause (or at age less than or equal to 50, if age at menopause is unknown).

OR

The subject is of Ashkenazi ancestry and has had breast cancer herself. To meet this criterion, her breast cancer must have been diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown).

OR

The probability of carrying a BRCA1/2 mutation given the family pedigree of breast and OCs exceeds 20% as calculated by BRCAPRO.

Note: BRCAPRO does NOT need to be calculated on everyone who enters the study. Patients are eligible based on a family history which meets one of the specific patterns described in this protocol, regardless of BRCAPRO results. BRCAPRO assessment is valuable in families where genetic testing has not been done, and the family history does not fit one of the specific patterns described, but the pattern of cancers leads you to believe that the family might still be considered high-risk. At that point, if the BRCAPRO estimate of being a mutation carrier is greater than 20 percent, then the patient IS eligible.

Signed an approved informed consent and authorization permitting release of personal health information.

EXCLUSION CRITERIA:

A first- or second-degree relative has a deleterious BRCA1/2 mutation, and the subject has tested NEGATIVE for the exact same mutation.

Women who are currently pregnant or planning pregnancy during the study.

Women who are participating in another OC early detection trial (except for the ROCA study being run by the Cancer Genetics Network. Women who have enrolled in the ROCA study and who subsequently choose to undergo surgery may enroll in the surgical cohort of GOG 0199).

Women with psychiatric, psychological or other conditions which prevent fully informed consent.

Women with current untreated malignancy (excluding non-melanoma skin cancer).

Women with adjuvant radiation therapy or chemotherapy within the past 1 month (31 days). For purposes of this study, any biologic agent administered with an anti-cancer therapeutic intent (e.g., Herceptin) will also not be permitted.

Women who have been treated for prior metastatic malignant disease within the past 5 years.

Women who have undergone intraperitoneal surgery within the prior 3 months (includes laparoscopy).

Women who have had both ovaries removed prior to study entry.

Women with a history of any medical condition which places the subject at risk related to the need for donating blood for research purposes, e.g., chronic infectious diseases, severe anemia, hemophilia.

Note: Enrollment of women in whom there is a significant pre-operative clinical suspicion that there might exist ovarian or fallopian tube caner should be avoided. The intent of the study is to ascertain subjects who are contemplating a risk-reducing, rather than a therapeutic, procedure. Women with findings of uncertain significant on baseline TVUS remain eligible.

National Cancer Institute (NCI)

Screening Oophorectomy Hereditary Genetics Cancer

Layout table for MeSH terms

Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications	Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type