Clinical trial NCT00849199: Cancer Screening and Prevention Program for High Risk Women
Official title: Cancer Screening and Prevention Program for High Risk Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Breast Cancer
Keywords: screening
early detection
prevention
cancer
high risk
ovarian cancer
breast cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Lynne Cohen Foundation for Ovarian Cancer Research
First posted: 2009-02-23
Enrollment: 1452
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primarily disadvantaged women who have a family history of breast and or ovarian cancer or 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: To create a registry for women at high risk of breast or ovarian cancer
timeFrame: 15 years
Secondary outcomes:
measure: 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
timeFrame: 15 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: NYU Cancer Center
state: New York
city: New York
country: United States
facility: NYU Tisch Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Franco Muggia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Ecancermedicalscience. 2009;3:123. doi: 10.3332/ecancer.2008.123. Epub 2009 Mar 16.