JH GeneTech Launches China's Largest Multicenter Clinical Study for Endometrial Cancer Screening and Establishes International Alliance

On November 7, 2021, Beijing Cispoly Biotechnology Co., Ltd. (“Cispoly”), an innovative high-tech enterprise focused on early diagnostic products for gynecological tumors, and several top-tier hospitalsLaunch the EndoMethy Project: A Multicenter Cohort Study on Early Screening and Diagnosis of Endometrial Cancer Based on Cervical Cytology MethylationRenowned gynecologic oncology experts from multiple collaborating institutions jointly discussed the clinical significance and feasibility of the project, and designed this multicenter clinical study. The EndoMethy project is expected to serve as evidence for endometrial cancer screening in China, contributing to the establishment of Chinese guidelines for early screening of endometrial cancer. In alliance with international gynecological societies, the project aims to conduct clinical studies across diverse populations and strengthen the evidence base for early screening of endometrial cancer, thereby influencing other national medical associations in formulating their own guidelines for early detection of endometrial cancer.

A Multicenter Cohort Study of Cervical Cytology for Endometrial Cancer Screening: The First and Largest Population-Based, Methylation-Driven Multicenter Cohort Study on Endometrial Cancer Screening in China (EndoMethy)Led by Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences and supported by cispoly, this initiative was jointly conducted with 12 other large Grade A tertiary hospitals, listed in alphabetical order by their Chinese names: Beijing International Hospital of Peking University, Obstetrics and Gynecology Hospital of Fudan University, Cangzhou Central Hospital (Hebei Province), The Second Hospital of Jilin University, Nanjing Maternity and Child Health Care Hospital, People's Hospital of Inner Mongolia Autonomous Region, Shaanxi Provincial People's Hospital, Luohu District People's Hospital of Shenzhen, The Second Affiliated Hospital of Soochow University, Beijing Tiantan Hospital of Capital Medical University, and The Third Xiangya Hospital of Central South University.

At the kickoff meeting, Professor Zhu Lan, the lead investigator of the multicenter clinical study, introducedEndoMethy ProjectThis is the first and largest-scale multicenter clinical trial in China focused on endometrial cancer screening. It has fully achieved its clinical research objectives, aiming to identify and establish minimally invasive biomarkers for early detection of endometrial cancer. The study seeks to explore more objective, reproducible, and highly specific detection methods for early-stage endometrial cancer and even precancerous lesions, thereby filling the current gap in endometrial cancer screening strategies and providing evidence-based guidance for clinical practice.

Professor Li Lei from Peking Union Medical College Hospital, on behalf of the research team, presented a report titled “Multicenter Cohort Study on Endometrial Cancer Screening Based on Methylation Biomarkers,” sharing insights based on preliminary work and introducing the implementation plan for the multicenter cohort study:

1. Preliminary Evidence of a Strong Association Between Cervical Brush Cytology Detection of Specific Methylated Genes and Endometrial Cancer: An exploratory trial using cervical cell DNA methylation for endometrial cancer screening has completed its preliminary phase, led by Peking Union Medical College Hospital in collaboration with Cangzhou Central Hospital, Inner Mongolia People's Hospital, and Peking University International Hospital, among others, having collected at least 20,000 samples.

2. Heke'an Cis-Endom^TMWith an 88% detection rate and 95% specificity for early-stage endometrial cancer, it significantly outperforms symptom- and imaging-based diagnostic approaches, thereby filling the gap in effective methods for early screening and diagnosis of endometrial cancer.NoteCis-Endom^TMCan serve as an independent screening indicator；

3. The kickoff meeting outlined a multi-center implementation plan and further analyzed the clinical practice guidelines for using cervical cytology methylation in endometrial cancer screening. The protocol comprises two phases and four key components: Phase I involves distinct enrollment strategies designed for outpatient clinics, hysteroscopy suites, and operating rooms; Phase II aims to conduct screening and follow-up among community populations to complete post-market universal screening.

The multicenter clinical research project on endometrial cancer screening has received full recognition and support from numerous experts, sparking lively exchanges and discussions among the attending scholars and experts at the conference.

Professor Zhu Lan concluded by stating,EndoMethy ProjectSuccessful implementation can provide a crucial evidence base for domestic guidelines addressing significant challenges, such as the lack of effective endometrial cancer screening strategies, the trend toward younger onset with fertility preservation needs, the prevalence of thickened endometrium in non-cancerous populations, and the high volume of hysteroscopies required for patients with vaginal bleeding. By serving as robust Chinese evidence, these findings can influence international guidelines and benefit more women through early screening strategies.

Based on this, the first large-scale, multicenter clinical study on endometrial cancer screening in China was launched under the advocacy of Professor Zhu Lan, along with the establishment of the Endometrial Cancer Screening Alliance. The EndoMethy project is expected to serve as evidence for endometrial cancer screening in China, helping to establish Chinese guidelines for early endometrial cancer screening. By forming an alliance with international gynecological societies to conduct clinical studies across different populations and strengthen the evidence base for early endometrial cancer screening, the project aims to influence other national medical associations in developing their own guidelines for early endometrial cancer screening.