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Study Summary
No. GOG-0199:.......Ovary; Gynecology; Fallopian Tube; Peritoneum......Karen H. Lu......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
GOG-0199
Study Title:Prospective Study of Risk-Reducing Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer
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Physician New Patient Referral
Name:Karen H. LuPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-8902
Contact us about clinical trials
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General Information
Disease Group:Ovary
Gynecology
Fallopian Tube
Peritoneum
Supported By:Gynecologic Oncology Group
Phase of Study:Phase IIIReturn
Visit:
Once every six months for CA-125 (and serum and plasma donation for tissue bank if agreed by participant). Participants will be followed for a period of 5 years.
Treatment
Agents:
NoneHome Care:Completion of QOL instruments every 6 months.
Treatment Loc:both inpatient and outpatient
Estimated
Length of Stay
in Houston:
One hospitalization for RRSO; approximately 5 days inpatient.
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:10/20/2003
IRB Review and Approval Date:09/17/2003
Study Type:Screening
Recruitment Status:Closed
Projected Accrual:120
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:Age greater than or equal to 30

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

Ovary status: (a) To be eligible for the RRSO arm of this study, subjects must have at least one intact ovary- (b) To be eligible for the screening arm of this study which targets primary ovarian cancer as the endpoint, subjects must have at least one intact ovary- (c) To be eligible for the screning arm of this study which targets primary peritoneal cancer as the endpoint, both ovaris and fallopian tubes must have been removed (women w/removal of ovaries while on GOG-0199).

Women who have not had both ovaries removed prior to study entry.

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 be diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown)

The subject is of Ashkenzai Jewish ethnicity with one first degree or two second degree relatives with breast and/or ovarian cancer. 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)

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)

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.

Probability of carrying a BRCA1/2 mutation given fam pedigree of breast and OC's exceed 20% calc by BRCAPRO. Note:BRCAPRO does NOT need to be calc on everyone. Pt elig based on fam hx which meets 1 of specific patterns desc regardless of BRCAPRO result. BRCAPRO is valuable in fam where genetic testing hasnt been done and fam hx doesnt fit 1 of specific patterns desc but patterns of ca indicate fam might still be consid high-risk. Then if BRCAPRO est of being a mutation carrier is >20%
pt IS elig

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

Exclusion Criteria:A first or second degree relative has deleterious BRCA1/2 mutation and the subject tested negative for the exact same mutation.

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

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

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

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 with a history of a 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 or hemophilia).

Women with adjuvant radiation therapy or chemotherapy within the past 1 month (31 days)

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 GOG0199).

NOTE: Enrollment of women in whom there is a significant pre-operative clinical suspicion that there might exist ovarian or fallopian tube cancer 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 significance on baseline TVUS remail eligible.

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Links
Registration Number: NCT00049049
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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