NCT06672341Not yet recruiting
Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation
A Prospective, Open, Observational Clinical Study on Endometrial Cytology and Cervical Methylation Testing for Screening and Evaluating Fertility-Sparing Treatment in Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 1 Nov 2024
- Start date
- 4 Nov 2024
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Yulan Ren
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT06672341
What you commit to
- Study type: Observational
- Planned participants: 200
- From 4 Nov 2024 to the primary completion date, 1 Nov 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants meeting any of the following criteria will be excluded:
- Diagnosed with cervical cancer.
- Severe systemic complications preventing hysteroscopy.
- Pregnant or recent history of miscarriage.
- Acute genital tract infection or pelvic inflammatory disease.
- Insertion of an intrauterine device.
- Sexual activity, vaginal douching, or medication use within 24 hours.
Who the study is looking for
- Participants must meet all of the following criteria to be eligible for the study:
- 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.
Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.