Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas

New Test Explores Uterine Lavage for Ovarian Cancer Detection

NCT: NCT03606486 · Status: TERMINATED · Phase: N/A · Sponsor: University of Washington · Started: 2018-11-16 · Est. Completion: 2022-12-09

Plain English Summary

Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer is a Not Applicable clinical trial sponsored by University of Washington studying 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. This study tested a new, less invasive method to find ovarian cancer by looking for cancer-related changes in uterine fluid and Pap smear samples. It was designed for women with suspected advanced ovarian cancer or those with a higher genetic risk of developing the disease. Participation involved collecting samples during surgery for cancer removal, alongside a Pap smear and uterine fluid wash. The study aimed to compare this new method with existing tumor analysis to find the best way to detect ovarian cancer early. The trial aims to enroll 52 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women with suspected advanced ovarian cancer or a known genetic risk for ovarian cancer. Must be scheduled for surgery to remove suspected or confirmed ovarian cancer. Must have a uterus and have not had their fallopian tubes blocked. Cannot participate if they cannot speak English, cannot give consent, or have had their uterus removed. This trial is studying 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, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal was to see if a specific genetic marker for ovarian cancer could be found in uterine fluid samples from 20 participants, indicating the test's potential to detect the disease. The specific primary outcome measures are: 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage (A single point in time after sample collection, no follow-up of participants is done). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial sought to develop a simpler, less invasive method for detecting ovarian cancer, addressing a need for earlier and more accessible diagnostic tools. This research targets 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, where improved treatment options are needed.

Investor Insight

While terminated, this trial explored a novel diagnostic approach for a common and often late-diagnosed cancer, signaling potential innovation in the ovarian cancer diagnostics market.

Is This Trial Right for Me?

Ask your doctor if this type of uterine lavage and Pap smear collection is appropriate for you, especially if you are undergoing surgery for suspected ovarian cancer. Participation involves providing samples during your scheduled surgery, which includes a uterine wash and a Pap smear, with no further follow-up required after sample collection. The samples will be analyzed in a lab to look for specific genetic changes associated with ovarian cancer. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT03606486?

NCT03606486 is a Not Applicable INTERVENTIONAL study titled "Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer." It is currently terminated and is sponsored by University of Washington. The trial targets enrollment of 52 participants.

What conditions does NCT03606486 study?

This trial investigates treatments for 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. The primary condition under study is High Grade Ovarian Serous Adenocarcinoma.

What treatments are being tested in NCT03606486?

The interventions being studied include: Biospecimen Collection (OTHER), Laboratory Biomarker Analysis (OTHER), Lavage (DEVICE), Pap Smear (OTHER). Undergo collection of tumor sample and blood draw

What does Not Applicable mean for NCT03606486?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT03606486?

This trial is currently "Terminated." It started on 2018-11-16. The estimated completion date is 2022-12-09.

Who is sponsoring NCT03606486?

NCT03606486 is sponsored by University of Washington. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT03606486?

The trial aims to enroll 52 participants. The trial status is terminated.

How is NCT03606486 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT03606486?

The primary outcome measures are: 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage (A single point in time after sample collection, no follow-up of participants is done). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT03606486 being conducted?

This trial is being conducted at 1 site, including Seattle, Washington (United States).

Where can I find official information about NCT03606486?

The official record for NCT03606486 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03606486. This government database provides the most up-to-date and detailed information about the trial.

What is NCT03606486 testing in simple terms?

This study tested a new, less invasive method to find ovarian cancer by looking for cancer-related changes in uterine fluid and Pap smear samples. It was designed for women with suspected advanced ovarian cancer or those with a higher genetic risk of developing the disease.

Why is this trial significant?

This trial sought to develop a simpler, less invasive method for detecting ovarian cancer, addressing a need for earlier and more accessible diagnostic tools.

What are the potential risks of participating in NCT03606486?

The primary risk is related to the surgical procedure itself, which is already planned for cancer treatment. Potential discomfort or minor bleeding from the Pap smear and uterine lavage procedures. The study was terminated, meaning the results may not be fully available or conclusive. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT03606486?

Ask your doctor if this type of uterine lavage and Pap smear collection is appropriate for you, especially if you are undergoing surgery for suspected ovarian cancer. Participation involves providing samples during your scheduled surgery, which includes a uterine wash and a Pap smear, with no further follow-up required after sample collection. The samples will be analyzed in a lab to look for specific genetic changes associated with ovarian cancer. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT03606486 signal from an investment perspective?

While terminated, this trial explored a novel diagnostic approach for a common and often late-diagnosed cancer, signaling potential innovation in the ovarian cancer diagnostics market. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involved collecting samples during surgery for cancer removal, alongside a Pap smear and uterine fluid wash. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.