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NCT03606486 Clinical Trial

Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

Stage IV Ovarian Cancer AJCC v8 Clinical Trial

Official title:
Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03606486
Other study ID # 10019
Secondary ID NCI-2018-01242RG
Status Terminated
Phase N/A
First received
Last updated
Start date November 16, 2018
Est. completion date December 9, 2022

Study information
Verified date December 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Biospecimen Collection
Undergo collection of tumor sample and blood draw
• Laboratory Biomarker Analysis
Correlative studies
Device:
• Lavage
Undergo uterine lavage
Other:
• Pap Smear
Undergo pap smear

Locations
Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
University of Washington Minnesota Ovarian Cancer Alliance

Country where clinical trial is conducted

United States, 

Outcome
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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