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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Prospective Screening Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA 125 Screening in Participants at Increased Genetic Risk of Ovarian Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Prevention, Screening	Closed	30 and over	NCI	GOG-0199 NCI-02-C-0268, NCT00049049

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 30 years old
• No previous history of ovarian cancer or primary peritoneal cancer
• Willing to undergo testing for BRCA1 or BRCA2 genes
• At least 1 month since chemotherapy or radiation therapy
• At least 3 months intraperitoneal surgery (including laparoscopy)
• No previous surgery to remove both ovaries unless participating in GOG-0199 clinical trial
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will choose to be in one of two groups. All participants will complete questionnaires and undergo transvaginal ultrasound and measurement of CA125 levels.

Participants in group one will undergo measurement of CA 125 levels every 3 months and transvaginal ultrasound and mammography once a year. Some participants may undergo additional transvaginal ultrasound and laparotomy/laparoscopy. Participants may choose to undergo surgery to remove the fallopian tubes and ovaries at any time during the study.

Participants in group two will undergo surgery to remove the fallopian tubes and ovaries. They will then have CA 125 levels measured every 6 months and undergo a mammogram once a year. Some participants may undergo additional transvaginal ultrasound and laparotomy/laparoscopy.

Quality of life will be assessed before study treatment and at 6, 12, 24, and 60 months for some participants.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Mark Greene, MD, Protocol chair		Ph: 301-594-7641 Email: greenem@mail.nih.gov

Related Information

Featured trial article

Registry Information
Official Title		Prospective Study of Prophylactic Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer
Trial Start Date		2003-04-16
Registered in ClinicalTrials.gov		NCT00049049
Date Submitted to PDQ		2002-09-04
Information Last Verified		2006-11-03
NCI Grant/Contract Number		CA27469

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