Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

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.

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.

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

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.

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

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.

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.

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