NCT00267072

Brief Summary

The objectives of this study are:

  • To identify women at increased risk for developing ovarian cancer
  • To detect ovarian cancers at an early stage
  • To investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

8.9 years

First QC Date

December 19, 2005

Last Update Submit

January 5, 2018

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Asymptomatic women over the age of 45 with one or both ovaries.
  • Women over the age of 25 with one or both ovaries and any of the following:
  • A personal history of breast, colon or endometrial cancer or breast cancer gene (BRCA) 1 or 2 positive
  • First-degree relative (mother, sister, daughter) with ovarian or breast cancer
  • Two family members with either breast and/or ovarian cancer
  • Mother, sister, daughter, grandparent with a positive BRCA1 or BRCA2 genetic test result.
  • Past use of fertility drugs such as Clomid or Pergonal for more than a year.

You may not qualify if:

  • Women who are symptomatic of ovarian cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

  • Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.

    PMID: 11577478BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Cyril W. Helm, MD

    University of Louisville, James Graham Brown Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 20, 2005

Study Start

June 1, 2001

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

US(1)