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

NCT05647109 | Recruiting

• 1 other identifier: 2022PHB409
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Carcinoma Stage I; Atypical Endometrial Hyperplasia

Keywords

Progesterone; Patient-derived tumor-like cell clusters; Endometrial Carcinoma

Outcome Measures

Primary Outcomes (2)

• sensitivity

  The sensitivity of the prediction model

  7 months

• accuracy

  The accuracy of the prediction model

  7 months

Secondary Outcomes (2)

• false-negative rate

  7 months

• false-positive rate

  7 months

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention

Set of training; Set of verification

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University: collaborator
• Beihang University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fresh residual tissue available through biopsy

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

WANG JIANLIU, PhD/MD

CONTACT

8601088324383; wangjianliu1203@163.com

HE YIJIAO, PhD

CONTACT

+8618301512017; heyijiao2017@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctoral supervisor, Chief physician, Vice President

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: September 1, 2021
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)