Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

Not Applicable

Terminated

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

Interventions: Other: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Device: Lavage
Other: Pap Smear

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Diagnostic (pap smear, uterine lavage, tumor sample)	Biospecimen Collection	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.
Diagnostic (pap smear, uterine lavage, tumor sample)	Laboratory Biomarker Analysis	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.
Diagnostic (pap smear, uterine lavage, tumor sample)	Lavage	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.
Diagnostic (pap smear, uterine lavage, tumor sample)	Pap Smear	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.

Primary Outcome Measures

Name	Time	Method
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage	A single point in time after sample collection, no follow-up of participants is done	In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.

Secondary Outcome Measures