Ovarian Cancer Clinical Trial

Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

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 women with advanced ovarian cancer. The investigators plan a pilot study of 25 women with advanced ovarian cancer. Pap smear and uterine lavage samples will be collected while the woman 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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

With suspected advanced ovarian cancer
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 is for people with:

Ovarian Cancer

Estimated Enrollment:

60

Study ID:

NCT03606486

Recruitment Status:

Recruiting

Sponsor:

University of Washington

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States More Info
Barbara S. Norquist
Contact
206-616-1620
[email protected]
Barbara S. Norquist
Principal Investigator

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Study is for people with:

Ovarian Cancer

Estimated Enrollment:

60

Study ID:

NCT03606486

Recruitment Status:

Recruiting

Sponsor:


University of Washington

How clear is this clinincal trial information?

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