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.
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.
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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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