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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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
November 16, 2018
Primary Completion Date
December 9, 2022
Completion Date
December 9, 2022
Last Updated
January 17, 2024
52
ACTUAL participants
Biospecimen Collection
OTHER
Laboratory Biomarker Analysis
OTHER
Lavage
DEVICE
Pap Smear
OTHER
Lead Sponsor
University of Washington
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
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