Cancer Screening and Prevention Program for High Risk Women

Completed

• Conditions: Ovarian Cancer; Breast Cancer

• Registration Number: NCT00849199
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to collect information from a large group of women who may have a greater chance to develop cancer because of their own personal history of cancer or because of their family history of cancer.

Detailed Description

The objectives of this study are to be a resource of information on women's cancers, including the availability of a genetics counselor for women at risk for hereditary cancer, especially ovarian cancer; to provide referrals for diagnostic tests and appropriate clinics involved in early detection of cancer; to provide access to clinical trials and investigational screening methods in cancer early detection and prevention, whenever applicable; to provide women with educational materials; to develop a database of information compiled from the questionnaires and clinics for use in future studies; to create a registry of family history data from women of diverse racial and ethnic backgrounds who attend our clinic, i.e. who perceive themselves to be at increased risk of breast or gynecologic cancers.Women that participate in the study will be interviewed and asked to fill out a questionnaire. An assessment will then be made based on their information. Based on this assessment, women will be referred to the appropriate clinic or for diagnostic testing or provided with information regarding available protocol studies.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1452

Inclusion Criteria

• Female or male over the age of 18.
• Patients who have a family history of breast and or ovarian cancer.
• Patients who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.
• Patients who seek medical screening and risk assessment for perceived increased risk of breast or ovarian cancer.

Exclusion Criteria

• Women with psychiatric, psychological or other conditions which prevent fully informed consent.
• Patients seeking medical attention not related to the purposes of this protocol, (e.g. those seeking treatment of a known cancer).
• Women with a history of any 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To create a registry for women at high risk of breast or ovarian cancer	15 years

Secondary Outcome Measures

Name	Time	Method
To provide genetic counseling, referrals for diagnostic tests and to appropriate clinics to promote the early detection of cancer; to seek and develop research protocols of early detection and treatment	15 years

Trial Locations

Locations (3)

Bellevue Hospital; 🇺🇸 New York, New York, United States

NYU Cancer Center; 🇺🇸 New York, New York, United States

NYU Tisch Hospital; 🇺🇸 New York, New York, United States