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

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

Study Overview

• Status: Unknown
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: Tampons

Detailed Description

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. The bank will contain: 1) 10cc of blood drawn through venipuncture annually; 2) tampons placed in the patients vagina prior to surgery or clinic visit; 3) swabs of the endocervical canal; 4) freshly collected leftover and to-be-discarded tumors from ovarian, uterine, cervical, as well as leftover normal tissue, and ascites fluid, from samples collected for diagnostic purposes. These samples and patient-associated medical record data will be banked and used for future research and analyses. Samples will be saved in multiple formats for later tumor profiling (i.e. FFPE, snap frozen, in RNA-later, etc). These samples and information will be used to determine the underlying causes of cancers and chemoresistance, so that better methods of treatment, management, and prevention of gynecological cancers may be discovered in the future.

Samples will be linked and coded, with all HIPAA protected information removed, for storage and sharing with other investigators to protect patient information. Only coded samples and clinical information will be used in this protocol for when samples, information, and/or data are shared with other investigators at UVa or outside institutions in the future. A separate password protected/encrypted file will contain the patient identifiers and the key to the coded sample numbers. This file will only be accessible by the PI or study team listed on this protocol on UVa premises, and will only be stored on a UVa server behind the UVa firewall, and will not be stored or accessed on personal computers. Thus, identified patient information will not be accessible to any individual, except the PI or study team listed on this protocol, ensuring protection of patient information. In addition, coded patient samples and medical data from specimens obtained from the University of Alabama-Birmingham, that were previously collected by the PI under local IRB approval (IRB-HSR #18042), have been transferred to UVA under a fully executed MTA, and will be assimilated into this databank at UVa for future research.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Rachel M Lacy, MPH; Phone Number: 434-243-0126; Email: rmc9p@virginia.edu
• Study Contact Backup: Name: Charles Landen, MD; Phone Number: 434-924-9333; Email: CL3NJ@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Rachel Lacy, MPH; Phone Number: 434-243-0126; Email: rmc9p@virginia.edu
      • Contact: Charles Landen, MD; Phone Number: 434-924-9333; Email: CL3NJ@hscmail.mcc.virginia.edu
      • Principal Investigator: Charles Landen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Collection of tampons, blood, cervical swabs, tissue and ascites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish a bank of specimens at UVa	banking specimens for future testing	10 years

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Charles Landen, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2016
• Primary Completion (Anticipated): June 10, 2022
• Study Completion (Anticipated): June 10, 2022

Study Registration Dates

• First Submitted: November 17, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: tampons; ovarian cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: 18620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No