Clinical trial NCT03606486: Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer
Official title: Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Minnesota Ovarian Cancer Alliance
First posted: 2018-07-30
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
timeFrame: A single point in time after sample collection, no follow-up of participants is done
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Barbara S. Norquist
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rosana Risques
role: PRINCIPAL_INVESTIGATOR
References: