Stage IV Ovarian Cancer AJCC v8 Clinical Trial
Official title:
Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
Verified date | December 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 52 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
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: - Unable to speak English - Unable to provide informed consent - Prior hysterectomy |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Minnesota Ovarian Cancer Alliance |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage | In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer. | A single point in time after sample collection, no follow-up of participants is done |
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