Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Sc… (NCT06672341) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation
200 participantsStarted 2024-11-04
Plain-language summary
The current study aims to assess high-risk patients using both liquid-based cytology and cervical methylation testing. The results will be compared with the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of these methods for early detection of endometrial cancer, thereby evaluating their potential application in early screening.
Primary Objectives：
1. To evaluate the sensitivity, specificity, and accuracy of endometrial cytology for screening endometrial cancer.
2. To assess the sensitivity, specificity, and accuracy of methylation testing for screening endometrial cancer.
3. To perform further molecular testing on tissue samples obtained from endometrial cytology and cervical methylation tests, aiming to explore early screening-sensitive indicators.
Secondary Objectives：
1. To determine the value of endometrial cytology in evaluating the efficacy of fertility-sparing treatments for endometrial cancer.
2. To assess the value of methylation testing in evaluating the efficacy of fertility-sparing treatments for endometrial cancer.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Color Doppler ultrasound indicating intrauterine masses or abnormal endometrial thickening (for postmenopausal women not receiving hormone replacement therapy, endometrial thickness \>5mm).
. Patients undergoing follow-up and efficacy evaluation for fertility-sparing treatment of endometrial cancer or atypical endometrial hyperplasia.
. Patients with endometrial thickening following endocrine therapy for breast cancer.
. Signed informed consent form.
. Good compliance.
Exclusion criteria
. Diagnosed with cervical cancer.
. Severe systemic complications preventing hysteroscopy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
comparing to the traditional hysteroscopic pathological findings to determine the sensitivity and specificity of Endometrial Cytology and Cervical Methylation Testing
Timeframe: From enrollment to the end of treatment at 1 weeks