Cancer Screening and Prevention Program for High Risk Women

Breast Cancer Clinical Trial

Official title:

Cancer Screening and Prevention Program for High Risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849199
• Other study ID #: 9541
• Secondary ID: NYU H#9541
• Status: Completed
• Start date: July 2001
• Est. completion date: January 2018

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1452
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	Bellevue Hospital	New York	New York
United States	NYU Cancer Center	New York	New York
United States	NYU Tisch Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Lynne Cohen Foundation for Ovarian Cancer Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith J, Baer L, Blank S, Dilawari A, Carapetyan K, Alvear M, Utate M, Curtin J, Muggia F. A screening and prevention programme serving an ethnically diverse population of women at high risk of developing breast and/or ovarian cancer. Ecancermedicalscienc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To create a registry for women at high risk of breast or ovarian cancer		15 years
Secondary	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