Cancer Screening and Prevention Program for High Risk Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Lynne Cohen Foundation for Ovarian Cancer Research
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00849199
First received: February 20, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition
Ovarian Cancer
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cancer Screening and Prevention Program for High Risk Women

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • To create a registry for women at high risk of breast or ovarian cancer [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 15 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: July 2001
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
High risk of breast or ovarian 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849199

Contacts
Contact: Franco Muggia, MD 212-263-6485 franco.muggia@nyumc.org
Contact: Julia Smith, MD 212-263-7269 julia.smith@nyumc.org

Locations
United States, New York
Bellevue Hospital Recruiting
New York, New York, United States, 10016
NYU Cancer Center Recruiting
New York, New York, United States, 10016
NYU Tisch Hospital Recruiting
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Lynne Cohen Foundation for Ovarian Cancer Research
Investigators
Principal Investigator: Franco Muggia, MD New York University School of Medicine
  More Information

Publications:
Responsible Party: Franco Muggia, MD, NYU Cancer Institute
ClinicalTrials.gov Identifier: NCT00849199     History of Changes
Other Study ID Numbers: 00-60, NYU H#9541
Study First Received: February 20, 2009
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
screening
early detection
prevention
cancer
high risk
ovarian cancer
breast cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Breast Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Breast Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014