Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

NCT03606486 | Terminated Results FDA Device

• 3 other identifiers: 10019NCI-2018-01242RG1001786
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (pap smear, uterine lavage, tumor sample)

EXPERIMENTAL

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.

Other: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Device: Lavage; Other: Pap Smear

Interventions

Biospecimen Collection OTHER

Undergo collection of tumor sample and blood draw

Diagnostic (pap smear, uterine lavage, tumor sample)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (pap smear, uterine lavage, tumor sample)

Lavage DEVICE

Undergo uterine lavage

Also known as: Irrigation

Diagnostic (pap smear, uterine lavage, tumor sample)

Pap Smear OTHER

Undergo pap smear

Also known as: Cervical Smear Preparation, Cervical Smear Procedure, Pap Smear Procedure, Pap Test, Papanicolaou Smear Procedure, Papanicolaou Test, Vaginal Smears

Diagnostic (pap smear, uterine lavage, tumor sample)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to speak English
• Unable to provide informed consent
• Prior hysterectomy

Sponsors & Collaborators

• University of Washington: lead
• Minnesota Ovarian Cancer Alliance: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Therapeutic Irrigation; Papanicolaou Test; Vaginal Smears

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Diagnostic Techniques, Obstetrical and Gynecological

Results Point of Contact

• Title: Dr. Barbara Norquist
• Organization: University of Washington

bnorquis@uw.edu

206-543-3669

Study Officials

• Barbara S. Norquist

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Rosana Risques

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 30, 2018
• Study Start: November 16, 2018
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: January 17, 2024
• Results First Posted: January 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)