Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
| Registry | NCT03606486 |
|---|---|
| Status | Terminated - Terminated due to low accrual |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 52 (Actual) |
| Sponsor | University of Washington (Other); collaborators: Minnesota Ovarian Cancer Alliance |
| Conditions | 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 |
| Interventions | Biospecimen Collection, Laboratory Biomarker Analysis, Lavage, Pap Smear (Other, device) |
| Dates | start 2018-11-16, primary completion 2022-12-09, completion 2022-12-09, first posted 2018-07-30, last updated 2024-01-17 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for High Grade Ovarian Serous Adenocarcinoma All trials for Stage III Ovarian Cancer AJCC v8 All trials of Biospecimen Collection All trials of Laboratory Biomarker Analysis
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diagnostic (pap smear, uterine lavage, tumor sample) | Experimental | Other: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Device: Lavage; Other: 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. |
Sex: Female, ages: 18 Years to any
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
| Milestone | Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) |
|---|---|
| Started | 52 |
| Completed | 47 |
| Not completed | 5 |
Time frame: At the time of sample collection (during surgery).
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) | 0/52 (0.0%) | 0/52 (0.0%) | 0/52 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle, Washington | United States |