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Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

NCT03606486 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-01-17

Study results available
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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.

Conditions

  • High Grade Ovarian Serous Adenocarcinoma
  • Stage III Ovarian Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8

Interventions

OTHER

Biospecimen Collection

Undergo collection of tumor sample and blood draw

OTHER

Laboratory Biomarker Analysis

Correlative studies

DEVICE

Lavage

Undergo uterine lavage

OTHER

Pap Smear

Undergo pap smear

Sponsors & Collaborators

Principal Investigators

  • Barbara S. Norquist · Fred Hutch/University of Washington Cancer Consortium

  • Rosana Risques · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2022-12-09
Completion
2022-12-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606486 on ClinicalTrials.gov