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Clinical Trials/NCT03606486
NCT03606486
Terminated
Not Applicable

Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas

University of Washington1 site in 1 country52 target enrollmentNovember 16, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High Grade Ovarian Serous Adenocarcinoma
Sponsor
University of Washington
Enrollment
52
Locations
1
Primary Endpoint
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2018
End Date
December 9, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Norquist

Associate Professor

University of Washington

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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