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Spots Global Cancer Trial Database for Early Detection of Ovarian Cancer Using Plasma Cell-free DNA Fragmentomics (Prospective Study)

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Trial Identification

Brief Title: Early Detection of Ovarian Cancer Using Plasma Cell-free DNA Fragmentomics (Prospective Study)

Official Title: A Prospective Study of Early Detection of Ovarian Cancer Using Plasma Cell-free DNA Fragmentomics

Study ID: NCT05693987

Conditions

Ovarian Cancer

Interventions

Study Description

Brief Summary: The purpose of this study is to enable non-invasive early detection of ovarian cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage ovarian cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five diferent feature types, including Fragment Size Coverage (FSC), Fragment Size Distribution (FSD), EnD Motif (EDM), BreakPoint Motif (BPM), and Copy Number Variation (CNV) will be assessed to generate this model.

Detailed Description: At present, there are many problems in the detection of ovarian cancer in China, such as a large number of high-risk population, lack of effective screening and management methods, and the value of vaginal ultrasound and CA125 in early screening of ovarian cancer is limited. There is an urgent need for a more sensitive screening method for ovarian cancer in clinical practice. In a more advanced window period, a group with higher risk of disease will be screened to enter clinical diagnosis, so as to achieve early prevention and treatment of early patients and win valuable opportunities for effective prevention and treatment of ovarian cancer. Although there are some studies on early screening data of ovarian cancer at home and abroad, most of them use single detection dimension or somatic mutation combined with methylation analysis. At present, the optimization of detection technology, sample accumulation or validation of prospective clinical trials are still under way. In short, the space for early screening of ovarian cancer is vast, and liquid biopsy is non-invasive, convenient and easy to accept. It is an important technical means for early screening research of ovarian cancer, and has great potential to improve the performance of early screening of ovarian cancer. In order to further verify the application value of cfDNA-based fragmentomics in early screening of ovarian cancer and better screen the high-risk population of ovarian cancer in China, this study intends to analyze the characteristics of five cfDNA fragments based on low-depth whole-genome sequencing technology (WGS), and integrate artificial intelligence machine learning technology to establish a prediction model for early screening of ovarian cancer based on cfDNA.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Contact Details

Name: Bingzhong Zhang, MD

Affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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