Trial Outcomes & Findings for Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer (NCT NCT03606486)

Last Updated: 2024-01-17

Results Overview

In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.

Recruitment status

TERMINATED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

A single point in time after sample collection, no follow-up of participants is done

Results posted on

2024-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	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 Duplex sequencing. Biospecimen Collection: Undergo collection of tumor sample Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear
Overall Study STARTED	52
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Duplex sequencing. Biospecimen Collection: Undergo collection of tumor sample Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear
Overall Study Unable to collect sample	5

Baseline Characteristics

Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) n=52 Participants 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. Biospecimen Collection: Undergo collection of tumor sample and blood draw Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=99 Participants
Age, Categorical >=65 years	18 Participants n=99 Participants
Sex: Female, Male Female	52 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	45 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	52 participants n=99 Participants

PRIMARY outcome

Timeframe: A single point in time after sample collection, no follow-up of participants is done

Population: We were able to enroll 20 participants who ended up having ovarian cancer. We recruited less than expected due to the COVID19 pandemic and increased use of neoadjuvant chemotherapy.

In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.

Outcome measures

Outcome measures
Measure	Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) n=20 Participants 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 Duplex sequencing. Biospecimen Collection: Undergo collection of tumor sample Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage	13 Participants

Adverse Events

Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barbara Norquist

University of Washington

Phone: 206-543-3669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place