Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer

Recruiting

• Conditions: Atypical Endometrial Hyperplasia; Endometrial Carcinoma Stage I
• Interventions: Other: No intervention

• Registration Number: NCT05647109
• Lead Sponsor: Peking University People's Hospital

Brief Summary

To construct a prediction model of progesterone sensitivity in patients with endometrial cancer treated with fertility preservation

Detailed Description

After diagnosed of early endometrial carcinoma (EEC) or atypical endometrial hyperplasia (AEH) by hysteroscopy, patients meet the study criteria will be enrolled.

Patients will receive MPA (Medroxyprogesterone acetate) 250-500mg or MA (megestrol acetate) 160-320mg by mouth daily. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Hysteroscopy will continue until pathology confirms complete response. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR or SD. Patients with PD will be recommended for hysterectomy.

During each hysteroscopy, the intraoperative residual tissues were sent to the laboratory of College of Future Science and Technology of Peking University for culture as Patient-derived tumor-like cell clusters (PTC), and the content of lipids (lipid droplet size and cholesterol content) was measured by stimulated Raman scattering imaging and recorded. After collecting the data of 148 cases, the prediction model was constructed. Then the model is validated in the validation set composed of 96 new cases. In order to determine the accuracy and sensitivity of the model.

If a patient has achieved a pathological complete response and a high lipid content is detected in the tissue by stimulated Raman scattering imaging, we will follow up for subsequent recurrence.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-03
• Study First Posted: 2022-12-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 244

Inclusion Criteria

• Have a confirmed pathological diagnosis based upon hysteroscopy: atypical endometrial hyperplasia or histologically prove well-differentiated EEC G1 without myometrial invasion
• No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
• Have a desire for remaining reproductive function or uterus
• Good compliance with adjunctive treatment and follow-up

Exclusion Criteria

• Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
• Pregnancy or potential pregnancy
• Confirmed diagnosis of any cancer in reproductive system
• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
• Hypersensitivity or contradiction for using MPA or MA
• With other factors of reproductive dysfunction;
• Strong request for uterine removal or other conservative treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Set of training	No intervention	A total of 148 patients with endometrial cancer and atypical endometrial hyperplasia were included in the training set of the prediction model. They were divided into progesterone sensitive group and progesterone insensitive group.
Set of verification	No intervention	A verification set of the prediction model was established, consisting of 96 patients with endometrial cancer and atypical endometrial hyperplasia.

Primary Outcome Measures

Name	Time	Method
sensitivity	7 months	The sensitivity of the prediction model
accuracy	7 months	The accuracy of the prediction model

Secondary Outcome Measures

Name	Time	Method
false-positive rate	7 months	The false-positive rate of the prediction model
false-negative rate	7 months	The false-negative rate of the prediction model

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Pekín, Beijing, China