Cancer Screening and Prevention Program for High Risk Women

NCT ID: NCT00849199

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-07-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk of breast or ovarian cancer

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lynne Cohen Foundation for Ovarian Cancer Research

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franco Muggia, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Bellevue Hospital

New York, New York, United States

Site Status

NYU Cancer Center

New York, New York, United States

Site Status

NYU Tisch Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22275995 (View on PubMed)

Other Identifiers

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NYU H#9541

Identifier Type: OTHER

Identifier Source: secondary_id

9541

Identifier Type: -

Identifier Source: org_study_id

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