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2022-10-10
2023-10-12
2024-10-12
496
NCT05596435
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
OBSERVATIONAL
Early Detection of Pancreatic Cancer
The purpose of this study is to enable non-invasive early detection of pancreatic cancer in high-risk populations through the establishment of a machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage pancreatic cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and the status of KRAS gene mutation, will be assessed to generate this model.
The incidence of pancreatic cancer is insidious. Most patients were in advanced stage when diagnosed and could not be cured by surgery. Early diagnosis of pancreatic cancer through screening is so important. Early screening detection projects derived from liquid biopsy technology are not only limited to circulating DNA methylation markers, but have developed into multi-dimensional indicators for joint evaluation. This large-scale early detection study will randomly enroll 260 stage I/II/III pancreatic patients, 80 patients with pancreatic benign diseases and 156 age- and sex-matched healthy individuals upon providing written informed consent. Plasma samples will be collected and extracted cell-free DNA will be subjected to whole genome sequencing. We aimed to incorporate genome-wide copy number variations, cell-free DNA fragmentomics, and status of KRAS gene mutation into the development of a multimodal biomarker-based prediction model.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-10-24 | N/A | 2022-10-24 |
2022-10-24 | N/A | 2022-10-27 |
2022-10-27 | N/A | 2022-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Stage I-III pancreatic cancer Cell-free DNA collected from plasma samples of 260 patients with stage I-III pancreatic cancer will undergo whole-genome sequencing | OTHER: No intervention
|
| : Pancreatic disease Cell-free DNA collected from plasma samples of 80 patients with pancreatic benign disease will undergo whole-genome sequencing | OTHER: No intervention
|
| : Healthy controls Cell-free DNA collected from plasma samples of 100 non-cancer individuals will serve as controls | OTHER: No intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Area under curve of the model for detecting stage I/II/III pancreatic cancer | The area under curve of the model for the ultrasensitive early detection of stage I/II/III pancreatic cancer would be evaluate | 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Sensitivity of the early detection modell | The sensitivity of the model for the ultrasensitive early detection of stage I/II/III pancreatic cancer would be evaluate | 2 years |
| Specificity of the early detection model | The specificity of the model for the ultrasensitive early detection of stage I/II/III pancreatic cancer would be evaluate | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Gao Chuntao, MD Phone Number: 15822757365 Email: gaochuntao@tjmuch.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
