MDACC Study Summary GOG 0199

Study Summary
No. GOG 0199:.......Fallopian Tube; Ovary; Peritoneum......Karen H. Lu......Gynecologic Oncology

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

Physician

New Patient Referral



Name:	Karen H. Lu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring 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

General Information



Disease Group:	Fallopian Tube Ovary Peritoneum	Supported By:	N/A

Phase of Study:	N/A	Return 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:	Prophylactic Oophorectomy	Home Care:	none

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	One hospitalization for RRSO approximately 5 days inpatient.


Description/ Intervention:	The goal of this clinical research study is to learn more about how to care for women who are at increased risk of ovarian cancer, BRCA1 and BRCA2 are the two genes which cause most of the genetic forms of ovarian cancer. Women with changes ("mutations") in these genes are more likely to get ovarian cancer than women without changed BRCA1 or BRCA2 genes.

Study Objectives / Outcomes

1. To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal carcinoma and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known BRCA1/2 mutation carriers
a. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy (RRSO) and women who have elected screening
b. To compare the cancer rates between these two groups of women

2. To assess prospectively the prevalence of clinically occult ovarian cancer and fallopian tube cancer among women undergoing prophylactic salpingo-oophorectomy and to seek evidence of precursor lesions in the excised ovaries and fallopian tubes. This will include a new technique for collecting ovarian surface epithelium cells for both diagnostic cytology and for molecular studies.

3. To assess prospectively quality of life as a function of various management strategies among study participants. The specific quality of life aims are:
a. To measure and model baseline and subsequent evolution of overall quality of life, sexual functioning, frequency of menopausal symptoms, depression, anxiety, and concerns associated with familial (genetic or otherwise) risk of ovarian cancer in women who are undergoing screening and have undergone RRSO.
b. To determine whether overall quality of life, sexual functioning, frequency of menopausal symptoms, depression, anxiety, and concerns associated with familial (genetic or otherwise) risk of ovarian cancer differ at baseline and with respect to changes over time between women undergoing screening and women who have undergone RRSO.

4. To establish a longitudinal serum, plasma and tissue repository for retrospective evaluation of other promising biomarkers and genetic alterations with special relevance to familial (genetic or otherwise) ovarian and breast cancer risk.

Study Status Information



Study Activation / Registration Date:	10/20/2003

IRB Review and Approval Date:	04/12/2005

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	1000

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:

1) Age >/= 30

2) No prior history of ov ca, including LMP or PPSC of the peritoneum

3) At least one intact ovary.

4) Satisfied one of the following additional criteria (4-8): The family of the subject has a documented deleterious BRCA1 or 2 mutation – either: i. The subject herself has tested positive for a deleterious BRCA1 or 2 mutation or ii. The subject has a first- or second-degree relative with a deleterious BRCA1 or BRCA2 mutation OR

5) 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) OR

6) The subject is of Ashkenazi Jewish ethnicity with one first-degree or two second-degree relatives with breast and/or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer. 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

7) 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 eual to 50 if age at menopause is unknown) OR

8) The probability of carrying a BRCA1/2 mutation given the family pedigree of breast and ovarian cancers 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.

9) The subject has signed an approved informed consent.

Exclusion Criteria:

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

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

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

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

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

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

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

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

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

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

11) 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 this 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 remain eligible.

Links

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