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NCT04794322 · ClinicalTrials.gov registry record
Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer
A clinical trial of Ovarian Neoplasms and Fallopian Tube Neoplasms, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 250
- Enrollment target
- 6
- Study locations
NCT04794322: Recruiting study of Ovarian Neoplasms and Fallopian Tube Neoplasms, sponsored by Massachusetts General Hospital.
NCT04794322 is a study of Ovarian Neoplasms and Fallopian Tube Neoplasms that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 250 participants, below the 361-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (31% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04794322, a study of Ovarian Neoplasms and Fallopian Tube Neoplasms, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 6
- Study locations
Study Summary
The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis. Statistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.
Primary Outcome
Biomarkers that distinguish between ovarian cancer and benign ovarian disease
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Uterine lavage, or a wash of the womb
- DIAGNOSTIC_TEST Blood sample
- DIAGNOSTIC_TEST Pap smear
Study Locations (6)
Maryland
- Anne Arundel Health System - Annapolis
- Johns Hopkins University School of Medicine - Baltimore
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
California
- Kaiser Permanente - San Francisco - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
Washington
- The Swedish Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-04-13 |
| Est. Completion | 2028-08-31 |
What NCT04794322 shows while recruiting
NCT04794322 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 361-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (31% lower).
The record links to 10 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Uterine lavage, or a wash of the womb is the first listed.
NCT04794322 lists 6 locations in 5 states (Maryland, Arkansas, California).
Frequently Asked Questions
What is clinical trial NCT04794322 about?
NCT04794322 is a clinical study titled "Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer". The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine wheth...
What is the current status of trial NCT04794322?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2020-04-13. Estimated completion is 2028-08-31.
What conditions does trial NCT04794322 study?
This clinical trial studies the following conditions: Ovarian Neoplasms, Fallopian Tube Neoplasms, Stage III Ovarian Cancer AJCC v8, High Grade Ovarian Serous Adenocarcinoma, Ovarian Epithelial Carcinoma.
What interventions are being tested in trial NCT04794322?
The interventions under investigation include: Uterine lavage, or a wash of the womb (DIAGNOSTIC_TEST), Blood sample (DIAGNOSTIC_TEST), Pap smear (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04794322?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04794322 being conducted?
This trial has 6 study locations across Arkansas, California, Maryland, Massachusetts, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04794322's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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