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Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01139957
Recruitment Status : Unknown
Verified June 2015 by Gynecologic Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : June 9, 2010
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.

Condition or disease Intervention/treatment
Breast Carcinoma Fallopian Tube Carcinoma Ovarian Neoplasm Primary Peritoneal Carcinoma Procedure: Evaluation of Cancer Risk Factors Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Study of High Risk Factors

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (BRCA)1/2 mutation carriers.

II. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.

III. To compare the cancer rates between these two groups of women. IV. To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.

V. To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).

OUTLINE: This is a multicenter study.

Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.


Study Type : Observational
Estimated Enrollment : 1916 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants
Study Start Date : June 2010
Estimated Primary Completion Date : December 2015


Group/Cohort Intervention/treatment
Ancillary-correlative
Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.
Procedure: Evaluation of Cancer Risk Factors
Ancillary studies
Other Name: cancer risk factors evaluation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Study of High Risk Factors
Ancillary studies




Primary Outcome Measures :
  1. Breast cancer mortality rates [ Time Frame: Up to 5 years ]
  2. Ovarian cancer mortality rates [ Time Frame: Up to 5 years ]
    Cox proportional hazards models will be used to compare the incidence rates between the risk-reducing salpingo-oophorectomy (RRSO) and screening groups, adjusting for appropriate covariates. If necessary, modeling will be carried out in order to use non-proportional hazards models.

  3. Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer [ Time Frame: Up to 5 years ]
  4. Quality of life [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Woman at increased genetic risk of ovarian cancer
Criteria

Inclusion Criteria:

  • Enrolled on GOG-0199

    • Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
    • Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
    • No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139957


  Show 143 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark Greene Gynecologic Oncology Group

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01139957     History of Changes
Other Study ID Numbers: GOG-8199
NCI-2011-02233 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000674216
GOG-8199 ( Other Identifier: Gynecologic Oncology Group )
GOG-8199 ( Other Identifier: DCP )
GOG-8199 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Ovarian Neoplasms
Breast Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Carcinoma
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Breast Diseases
Skin Diseases
Fallopian Tube Diseases