NYU Ovarian Cancer Early Detection Program Blood and Gene... | NCT00531778

Studies
NYU Ovarian Cancer Early Detection Program Blood and Genetics

NCT00531778

Sponsor

NYU Langone Health

Status

Terminated

Last Update Posted

Jan 11, 2011Estimated

Enrollment

890Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient funding and resource

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Nov 2010Actual

First Submitted Date

Sep 18, 2007

First Submission Date that Met QC Criteria

Sep 18, 2007

First Posted Date

Sep 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.

This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

890Actual

Label	Type	Description	Intervention Names
NYU OCEDP Population

Measure	Description	Time Frame
identification and development of highly sensitive and specific tumor markers for ovarian cancer		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

women noted to be at increased risk for developing ovarian cancer

Sampling Method

Probability Sample

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases