High Grade Ovarian Serous AdenocarcinomaNCT03606486
Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer
A study testing Biospecimen Collection, Laboratory Biomarker Analysis and Lavage in people with High Grade Ovarian Serous Adenocarcinoma and Stage III Ovarian Cancer AJCC v8, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Ovarian Serous Adenocarcinoma, Stage III Ovarian Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Laboratory Biomarker Analysis and Lavage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to speak English
- Unable to provide informed consent
- Prior hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
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.
Read the 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.
- 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
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis, Lavage, Pap Smear
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
Undergo collection of tumor sample and blood draw
Laboratory Biomarker AnalysisOther
Correlative studies
LavageDevice
Also called Irrigation
Undergo uterine lavage
Pap SmearOther
Also called Cervical Smear Preparation, Cervical Smear Procedure, Pap Smear Procedure, Pap Test
Undergo pap smear
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Device: Lavage; Other: Pap Smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A single point in time after sample collection, no follow-up of participants is done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start16 Nov 2018
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: Terminated due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Grade Ovarian Serous AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Ovarian Cancer Alliance
- Responsible party
- Principal investigator, Barbara Norquist, University of Washington
- Investigators
- Barbara S. Norquist, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumRosana Risques, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606486
- Sponsor's protocol ID
- 10019
- Other IDs
- NCI-2018-01242, RG1001786
- Status last verified
- Dec 2023
- First submitted
- 20 Jul 2018
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
- ClinicalTrials.gov ID
- NCT03606486
- Acronym / sponsor ID
- 10019
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Minnesota Ovarian Cancer Alliance
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 17 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (pap smear, uterine lavage, tumor sample) | Experimental | Other: Biospecimen Collection, Other: Laboratory Biomarker Analysis, Device: Lavage, Other: Pap SmearParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to speak English
- Unable to provide informed consent
- Prior hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of tumor sample and blood draw | Other | Diagnostic (pap smear, uterine lavage, tumor sample) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (pap smear, uterine lavage, tumor sample) |
| LavageAlso: IrrigationUndergo uterine lavage | Device | Diagnostic (pap smear, uterine lavage, tumor sample) |
| Pap SmearAlso: Cervical Smear Preparation, Cervical Smear Procedure, Pap Smear Procedure, Pap TestUndergo pap smear | Other | Diagnostic (pap smear, uterine lavage, tumor sample) |
Primary outcome
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
Time frame: A single point in time after sample collection, no follow-up of participants is done
In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara S. Norquist principal investigator
Fred Hutch/University of Washington Cancer Consortium
Rosana Risques principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Laboratory Biomarker Analysis and Lavage in people with High Grade Ovarian Serous Adenocarcinoma and Stage III Ovarian Cancer AJCC v8, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage (time frame: A single point in time after sample collection, no follow-up of participants is done). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.