Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT04170712

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tampons

Study Details

Brief summary:

The purpose of this project is to establish a bank at UVa of tampon samples, cervical swabs, blood, associated tumor specimens that would otherwise be discarded, and relevant medical data from consenting patients that have suspected and/or confirmed gynecological cancer diagnoses. The specimens collected will be saved for analysis on future projects to determine if factors in the specimens are predictive and/or correlated to gynecological cancer diagnoses and/or outcomes

Conditions

Ovarian Cancer

Study ID

NCT04170712

Start date

Jun 10, 2016

Status verified date

Apr, 2020

Completion date

Jun 10, 2022

Anticipated

Primary completion date

Jun 10, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult female non-pregnant patients with high risk for gynecological and/or breast cancer who will be:

  • undergoing a planned surgery with the UVa Department of gynecological oncology for gynecological, breast, and/or related cancers and conditions
  • undergoing surveillance in the high-risk gynecological oncology clinic for gynecological, breast, and/or related cancers and conditions

Exclusion Criteria:

  • • Is under the age of 18

  • is pregnant

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical or High Risk

Patients with confirmed diagnosis of ovarian cancer or suspicious mass or who have a family history or genetic mutation that puts them at high risk fro ovarian cancer.

Interventions

Tampons

Collection of tampons, blood, cervical swabs, tissue and ascites

Primary outcome measure

  • To establish a bank of specimens at UVa [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Rachel M Lacy, MPH

434-243-0126rmc9p@virginia.edu

Charles Landen, MD

434-924-9333CL3NJ@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Rachel Lacy, MPH

434-243-0126rmc9p@virginia.edu

Charles Landen, MD

434-924-9333CL3NJ@hscmail.mcc.virginia.edu

Principal Investigator:

Charles Landen, MD

More Information

Sponsor

University of Virginia

Last update posted

Apr 20, 2020

Last verified

Apr, 2020

Keywords

  • tampons; ovarian cancer

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 2020-04-20.