Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

December 26, 2023 updated by: Barbara Norquist, University of Washington

Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas

The goal of this project is to develop a minimally invasive test to detect ovarian cancer, by searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and from the uterus (uterine lavage) in participants with advanced ovarian cancer and in participants with increased risk of ovarian cancer due to inherited mutations, such as BRCA or BRCA2 (among others).

Pap smear and uterine lavage samples will be collected while the participant is under anesthesia for planned debulking surgery. A novel, highly sensitive and accurate technique, Crispr-Duplex sequencing, will be used to detect tumor associated mutations in TP53 (the most commonly mutated gene in ovarian cancer) within these samples. These results will be compared to sequencing results in the tumor itself for comparison, and Pap and uterine lavage will be compared to each other to determine the optimal test. Ultimately, the goal is to use the results of this study to plan a larger study including women without cancer who are at either increased risk or normal risk of ovarian cancer, for use in early detection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OUTLINE:

Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • With suspected advanced ovarian cancer or genetic predisposition to malignant neoplasm of the ovary
  • Planned surgery
  • Have a uterus and no history of tubal occlusion

Exclusion Criteria:

  • Unable to speak English
  • Unable to provide informed consent
  • Prior hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (pap smear, uterine lavage, tumor sample)
Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Biospecimen Collection
Undergo collection of tumor sample and blood draw
Device: Lavage
Undergo uterine lavage
Other Names:
  • Irrigation
Other: Pap Smear
Undergo pap smear
Other Names:
  • Cervical Smear Preparation
  • Cervical Smear Procedure
  • Pap Smear Procedure
  • Pap Test
  • Papanicolaou Smear Procedure
  • Papanicolaou Test
  • Vaginal Smears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
Time Frame: A single point in time after sample collection, no follow-up of participants is done
In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.
A single point in time after sample collection, no follow-up of participants is done

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Minnesota Ovarian Cancer Alliance

Investigators

  • Principal Investigator: Barbara S. Norquist, Fred Hutch/University of Washington Cancer Consortium
  • Principal Investigator: Rosana Risques, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2018

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10019
  • NCI-2018-01242 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RG1001786 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

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

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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