NYU Ovarian Cancer Early Detection Program Blood and Genetics

NCT00531778 | Terminated

• 1 other identifier: NYU 04-30 H11938
• Study Type: observational
• Target: 890
• Locations: 1 country
• Sites: 1

Brief Summary

Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.

Conditions

Ovarian Cancer

Keywords

Women with increased risk for developing ovarian cancer; early detection; biomarker for ovarian cancer

Outcome Measures

Primary Outcomes (1)

• identification and development of highly sensitive and specific tumor markers for ovarian cancer

  5 years

Study Arms (1)

NYU OCEDP Population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

women noted to be at increased risk for developing ovarian cancer

You may qualify if:

• Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:
• A personal history of breast cancer
• One or more first degree relatives (mother, sister, daughter) with ovarian cancer
• Multiple family members with either breast and/or ovarian cancer
• A personal history of a positive BRCA1 or BRCA2 genetic test result
• A close relative with a positive BRCA1 or BRCA2 genetic test result
• A personal history of colon or endometrial cancer with at least two relatives with a Lynch/HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, or renal pelvis cancer)
• Synchronous or metachronous endometrial and colorectal cancer
• A personal history of a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
• A close relative with a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
• A personal history of colorectal or endometrial cancer with a mismatch repair defect (ie. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6, or PMS2)
• The use of fertility drugs for more than one year

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYUCancer Institute Clinical Cancer Center

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, urine, ovarian tissue

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Bhavana Pothuri, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: June 1, 2004
• Study Completion: November 1, 2010
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)