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Protocol Details

Extended Follow-up of High Ovarian Cancer Risk Cohort from 02C0268 (GOG-199)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-C-0033

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 18
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Keywords

Cancer;
Genetics;
Hereditary;
Screening;
Oophorectomy;
Natural History

Recruitment Keyword(s)

Ovarian Cancer Risk;
Breast Cancer Risk

Condition(s)

Breast Cancer;
Ovarian Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

- The National Cancer Institute and the Gynecologic Oncology Group are interested in continuing to follow participants in the National Cancer Institute study 02-C-0268, Prospective Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer. Women who participated in this study had a family history of ovarian cancer, and were originally scheduled to participate in the study for 5 years. However, it has become clear that more followup information after the first 5 years would help to study the frequency of ovarian cancer (including cancer in the fallopian tubes and cancer in the abdominal cavity) and breast cancer in women who are at increased risk of developing these cancers.

Objectives:

- To extend the followup period of National Cancer Institute study 02-C-0268 and collect additional information from participants.

Eligibility:

- Participants in the 02-C-0268 study who have completed the study s initial 5-year followup period, or who ended their participation on the study early because of pregnancy or a cancer diagnosis.

Design:

- This extended followup study will last up to 5 years.

- Participants will receive a short questionnaire (15 to 20 minutes to complete) once a year, and will be asked to return it to the address provided.

- Participants will be asked to provide updated contact information to allow study researchers to keep in touch over time. This information will include contact information for a friend or family member who would be contacted if the participant cannot be reached by mail, telephone, or e-mail.

- Participants who are diagnosed with cancer during the course of the new followup study will be asked for permission to allow the study researchers to obtain written confirmation of the specific cancer diagnosis from the participant's hospital or physician.

- Participants will receive an occasional newsletter with new findings from this study, as well as new findings or recommendations about hereditary breast/ovarian cancer.

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Eligibility

INCLUSION CRITERIA:

All GOG-0199 participants who have completed the original 5-year follow-up are eligible for enrollment in this extended study once they have completed the original 5-year follow-up.

Participants who have gone off study before the end of the initial 5-years follow-up period due to a cancer diagnosis requiring treatment with chemotherapy or due to pregnancy are eligible for enrollment in this study, provided that they have not developed an exclusion criterion

EXCLUSION CRITERIA:

Participants who have gone off study before the end of the initial 5-years follow-up period due to protocol violations or consent withdrawal.

A participant who was eligible for GOG-199 based on the presence of a BRCA deleterious mutation in a first- or second-degree relative, and who was subsequently tested negative for the family mutation would not be eligible even if she chose to remain on GOG-199 and completed the initial 5 years of follow-up.

Patients who do not meet the above criteria.


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Citations:

Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. Epub 2008 Feb 20.

Lux MP, Fasching PA, Beckmann MW. Hereditary breast and ovarian cancer: review and future perspectives. J Mol Med. 2006 Jan;84(1):16-28. Epub 2005 Nov 11.

Easton DF, Ford D, Bishop DT. Breast and ovarian cancer incidence in BRCA1-mutation carriers. Breast Cancer Linkage Consortium. Am J Hum Genet. 1995 Jan;56(1):265-71.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sharon A. Savage, M.D.
National Cancer Institute (NCI)
BG 9609 MEDICAL CENTER DRIVE RM 6E456
9609 MEDICAL CENTER DR.
ROCKVILLE MD 20850
(240) 276-7241
savagesh@mail.nih.gov

Sharon A. Savage, M.D.
National Cancer Institute (NCI)
BG 9609 MEDICAL CENTER DRIVE RM 6E456
9609 MEDICAL CENTER DR.
ROCKVILLE MD 20850
(240) 276-7241
savagesh@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01139957

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