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

Atypical Endometrial Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647109
• Other study ID #: 2022PHB409
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2024
• Source: Peking University People's Hospital
• Contact: WANG JIANLIU, PhD/MD
• Phone: 8601088324383
• Email: wangjianliu1203[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: October 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Endometrial Carcinoma Stage I
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Peking University People's Hospital	Pekín	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beihang University, Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity	The sensitivity of the prediction model	7 months
Primary	accuracy	The accuracy of the prediction model	7 months
Secondary	false-negative rate	The false-negative rate of the prediction model	7 months
Secondary	false-positive rate	The false-positive rate of the prediction model	7 months