Status:
UNKNOWN
Early Detection of Endometrial Cancer Using Plasma Cell-free DNA Fragmentomics
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Nanjing Geneseeq Technology Inc.
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to enable non-invasive early detection of endometrial cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-fr...
Detailed Description
Currently, there is no international consensus on the standard for endometrial cancer screening. The Expert Committee on Endometrial Cancer Screening in China released the "Expert Consensus on Endomet...
Eligibility Criteria
Inclusion
- Age minimum 18 years
- Patients diagnosed with early to mid-stage endometrial cancer (more than 50% are in FIGO stages I/II) through histological and/or cytological examination.
- Ability to understand and the willingness to sign a written informed consent document
- Participants can obtain comprehensive clinical and pathological information.
- Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening
Exclusion
- Participants must not be pregnant or breastfeeding
- Participants must not have prior cancer histories or a second non-endometrial malignancy
- Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
- Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
- Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
- Participants with clinically important abnormalities or conditions unsuitable for blood collection
- Any other disease or clinical condition of participants that the researcher believes may affect the compliance of the protocol, or affect the patient's signing of the informed consent form (ICF), which is not suitable to participate in this clinical trial.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06083779
Start Date
August 1 2023
End Date
April 30 2024
Last Update
October 16 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China