Pap smear upgrade? DNA test could spot hidden uterine cancer
NCT ID NCT07298707
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This observational study will test a new molecular test called CISENDO, which looks at DNA methylation in cells from a routine cervical smear. The goal is to see if it can accurately detect endometrial cancer or precancerous lesions in women at medium-to-high risk. Researchers will compare the test results to standard hysteroscopy with biopsy. If accurate, this could offer a less invasive way to screen for and monitor endometrial cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CISENDO test (DNA methylation test on cervical cytology samples)
- What this could lead to
- If successful, this could provide a simple, non-invasive screening test for endometrial cancer, reducing the need for invasive procedures like hysteroscopy.
- What could go wrong
- This is an early observational study, not a treatment trial. The test may not be accurate enough to replace current methods, and results may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 3,500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This multicenter, prospective cohort study aims to enroll approximately 3,500 adult women in China who are at medium-to-high risk for endometrial cancer according to Chinese clinical consensus guidelines. The study population specifically includes two groups: 1) women who are scheduled for a diagnostic hysteroscopy due to these risk factors, and 2) women who are currently undergoing conservative treatment (such as progesterone therapy or endometrial ablation) for existing endometrial lesions and have not received chemotherapy. All participants must have an intact cervix and be willing to participate in follow-up assessments. Participants will be followed for up to 12 months, with the enrollment target set to observe at least 20 endpoint events (diagnosis of endometrial intraepithelial neoplasia or invasive cancer).
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants must be 18 years of age or older. 2. Participants must possess medium-to-high risk factors for endometrial cancer as defined by Chinese consensus guidelines and are scheduled for hysteroscopic evaluation; OR are currently undergoing conservative treatment (e.g., progesterone therapy or endometrial ablation) for endometrial lesions, and have not received chemotherapy. 3. Participants must be capable and willing to provide written informed consent. 4. Participants must be willing to undergo at least one follow-up assessment within 1 year. 5. Participants must have an intact cervix (a history of LEEP or conization is acceptable). Exclusion Criteria: 1. Current treatment for any gynecologic malignancy other than endometrial cancer. 2. Current or untreated cervical, vaginal, or vulvar intraepithelial neoplasia or carcinoma. 3. History of total or subtotal hysterectomy, trachelectomy, radical trachelectomy, or pelvic radiotherapy. 4. Active lower genital tract bleeding. 5. Immunosuppressed state (e.g., HIV infection, status post organ transplantation). 6. Failure to undergo the planned hysteroscopic evaluation and follow-up within 1 year after the initial assessment. 7. Failed hysteroscopic procedure. 8. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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