Clinical Studies of Endometrial Cytology and Cervical Methylation Assays in Endometrial Cancer Screening and Fertility-Preservation Evaluation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorYulan Ren

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Diagnosed with cervical cancer.

Severe systemic complications preventing hysteroscopy.

Pregnant or recent history of miscarriage.

Acute genital tract infection or pelvic inflammatory disease.

Trial design

Treatments tested in this trial

  • Endometrial Cytology Testing
  • Cervical Methylation Testing

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Yulan Ren

Lead sponsor

Fudan University

Sponsor institution