Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas

Conditions
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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

Intervention / Treatment
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* Other: Biospecimen Collection
* Other: Laboratory Biomarker Analysis
* Device: Lavage
* Other: Pap Smear


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (pap smear, uterine lavage, tumor sample)<br>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. | Other: Biospecimen Collection<br>* Undergo collection of tumor sample and blood draw<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Device: Lavage<br>* Undergo uterine lavage<br>* Other names: Irrigation;Other: Pap Smear<br>* Undergo pap smear<br>* Other names: Vaginal Smears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of pap smear versus sensitivity of uterine lavage in detection of tumor-derived TP53 mutations | Pap smear and uterine lavage samples will be sequenced for TP53 mutations using the Crispr-Duplex Sequencing method. Primary tumors will be sequenced in order to confirm that the mutations identified in the Pap and/or uterine lavage are present in the tumor. | Up to 1 year | 
| Specificity of pap smear versus specificity of uterine lavage in detection of tumor-derived TP53 mutations | Pap smear and uterine lavage samples will be sequenced for TP53 mutations using the Crispr-Duplex Sequencing method. Primary tumors will be sequenced in order to confirm that the mutations identified in the Pap and/or uterine lavage are present in the tumor. | Up to 1 year |