Recruiting

Ovarian Cancer

Sponsor:

University of Virginia

Code:

NCT01187602

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.

Conditions

Ovarian Cancer

Study ID

NCT01187602

Start date

Aug, 2010

Status verified date

Dec, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Undergoing medical care at UVA
  • Up to date breast cancer screening
  • Subjects must fall into one of the following groups:

  • Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries.
  • Women at average risk for ovarian cancer
  • Women with known/suspected or recurrent ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center

Exclusion Criteria:

  • Subjects with increased risk for ovarian cancer may not have a history of prior malignancy within the last 10 years excluding cervical carcinoma in situ or basal cell carcinoma
  • Pregnancy (self reported)

Study Design

Enrollment

103 participants

Anticipated

Interventions and Outcome Measures

Arms

Women at average risk for ovarian cancer

Women at average risk for ovarian cancer (no first degree relatives with breast or ovarian cancer) undergoing gynecologic evaluation at UVA for non-malignant or routine indications.

Women with ovarian cancer

Women with known or suspected ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center

Increased risk for ovarian cancer

Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries.

Primary outcome measure

  • Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer [ Time Frame: 24 months ]
  • Identification of serum derived sncRNA biomarkers that correlate with disease burden in ovarian cancer. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Susan Modesitt, MD

434-924-5197scm6h@virginia.edu

Heather L Lothamer, MSN

434-924-9924hll5y@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Heather Lothamer, MSN

434-924-9924hll5y@virginia.edu

Susan Modesitt, MD

434-243-5197

Principal Investigator:

Susan Modesitt, MD

More Information

Sponsor

University of Virginia

Last update posted

Dec 5, 2014

Last verified

Dec, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2014-12-05.