Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-16

Study Completion Date

2022-12-09

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 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.

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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.

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (pap smear, uterine lavage, tumor sample)

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type OTHER

Undergo collection of tumor sample and blood draw

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Lavage

Intervention Type DEVICE

Undergo uterine lavage

Pap Smear

Intervention Type OTHER

Undergo pap smear

Interventions

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Biospecimen Collection

Undergo collection of tumor sample and blood draw

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Lavage

Undergo uterine lavage

Intervention Type DEVICE

Pap Smear

Undergo pap smear

Intervention Type OTHER

Other Intervention Names

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Irrigation Cervical Smear Preparation Cervical Smear Procedure Pap Smear Procedure Pap Test Papanicolaou Smear Procedure Papanicolaou Test Vaginal Smears

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