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Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03606486
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Minnesota Ovarian Cancer Alliance
Information provided by (Responsible Party):
University of Washington

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 women with advanced ovarian cancer. The investigators plan a pilot study of 25 women with advanced ovarian cancer. Pap smear and uterine lavage samples will be collected while the woman 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.

Condition or disease Intervention/treatment Phase
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 Other: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Lavage Other: Pap Smear Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To collect samples from at least 25 women with advanced, high-grade serous ovarian carcinoma (OC), including Papanicolaou (pap) smears, uterine lavage, and a tumor sample.

II. To test the deoxyribonucleic acid (DNA) from pap smears and uterine lavage samples for tumor-derived TP53 mutations, using the new technology of Crispr-Duplex sequencing.

III. Determine the sensitivity and specificity of Pap smear or uterine lavage in detection of tumor-derived TP53 mutations.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: Diagnostic (pap smear, uterine lavage, tumor sample)
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
Undergo collection of tumor sample and blood draw

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Lavage
Undergo uterine lavage
Other Name: Irrigation

Other: Pap Smear
Undergo pap smear
Other Names:
  • Cervical Smear Preparation
  • Cervical Smear Procedure
  • Pap Smear Procedure
  • Pap Test
  • Papanicolaou Smear Procedure
  • Papanicolaou Test
  • Vaginal Smears




Primary Outcome Measures :
  1. Sensitivity of pap smear versus sensitivity of uterine lavage in detection of tumor-derived TP53 mutations [ Time Frame: Up to 1 year ]
    Pap smear and uterine lavage samples will be sequenced for TP53 mutations using the Crispr-Duplex Sequencing method. Primary tumors will be sequenced in order to confirm that the mutations identified in the Pap and/or uterine lavage are present in the tumor.

  2. Specificity of pap smear versus specificity of uterine lavage in detection of tumor-derived TP53 mutations [ Time Frame: Up to 1 year ]
    Pap smear and uterine lavage samples will be sequenced for TP53 mutations using the Crispr-Duplex Sequencing method. Primary tumors will be sequenced in order to confirm that the mutations identified in the Pap and/or uterine lavage are present in the tumor.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • With suspected advanced ovarian cancer
  • Planned surgery
  • Have a uterus and no history of tubal occlusion

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606486


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Barbara S. Norquist    206-616-1620    bnorquis@uw.edu   
Principal Investigator: Barbara S. Norquist         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Minnesota Ovarian Cancer Alliance
Investigators
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Principal Investigator: Barbara Norquist Fred Hutch/University of Washington Cancer Consortium
Principal Investigator: Rosana Risques Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03606486    
Other Study ID Numbers: 10019
NCI-2018-01242 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10019 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cystadenocarcinoma, Serous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous