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

Department of Obstetrics & Gynecology ，Peking University People's Hospital

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

Study Overview

• Status: Recruiting
• Conditions: Atypical Endometrial Hyperplasia; Endometrial Carcinoma Stage I
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 244

Contacts and Locations

• Study Contact: Name: WANG JIANLIU, PhD/MD; Phone Number: 8601088324383; Email: wangjianliu1203@163.com
• Study Contact Backup: Name: HE YIJIAO, PhD; Phone Number: +8618301512017; Email: heyijiao2017@pku.edu.cn

Study Locations

• China
  • Beijing
    • Pekín, Beijing, China
      • Recruiting
      • Peking University People's Hospital
      • Contact: WANG JIANLIU, PHD/MD; Phone Number: +86108832438; Email: wangjianliu1203@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study focused on young, pre-menopausal patients with atypical endometrial hyperplasia or endometrioid adenocarcinoma diagnosed by hysteroscopic biopsy, who had a strong desire to preserve reproductive function.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Set of training; 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.	Other: No intervention; No intervention
Set of verification; A verification set of the prediction model was established, consisting of 96 patients with endometrial cancer and atypical endometrial hyperplasia.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity	The sensitivity of the prediction model	7 months
accuracy	The accuracy of the prediction model	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
false-negative rate	The false-negative rate of the prediction model	7 months
false-positive rate	The false-positive rate of the prediction model	7 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University; Beihang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Endometrial Carcinoma; Progesterone; Patient-derived tumor-like cell clusters
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hyperplasia; Endometrial Hyperplasia; Endometrial Neoplasms
• Other Study ID Numbers: 2022PHB409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No