Endometrial lesions
Conditions
Interventions
Gold Standard:Histopathological diagnosis (hysteroscopic biopsy or diagnostic curettage pathology)
Index test:Cervical cytology sample DNA methylation detection (CISENDO test)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity; | — |
Countries
China
Contacts
Public ContactLei Li
Peking Union Medical College Hospital
Outcome results
None listed