Data and Specimen Bank of Patients Diagnosed With, and at High-risk for, Gynecologic Cancers

NCT04170712 | Unknown DMC

• 1 other identifier: 18620
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

tampons; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• To establish a bank of specimens at UVa

  banking specimens for future testing

  10 years

Study Arms (1)

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.

Other: Tampons

Interventions

Tampons OTHER

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

Surgical or High Risk

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed ovarian cancer diagnosis or suspicious mass or patients with a strong family history of ovarian cancer or genetic mutation that puts them at high risk for ovarian cancer

You may qualify if:

• 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

You may not qualify if:

• Is under the age of 18
• is pregnant

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tampons, swabs, blood and tissue will be collected prospectively to establish a bank of samples fro future testing for markers, risk factors and targets for ovarian cancer prevention, detection and treatment

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

• Charles Landen, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel M Lacy, MPH

CONTACT

434-243-0126; rmc9p@virginia.edu

Charles Landen, MD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 20, 2019
• Study Start: June 10, 2016
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)