Clinical trial NCT05596435: Early Detection of Pancreatic Cancer
Official title: Early Detection of Pancreatic Cancer Using Plasma Cell-free DNA Fragmentomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 260 stage I/II/III gastric cancer patients, 70 patients with pancreatic benign diseases and 150 non-cancer controls

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age minimum 18 years
* Participants must have histologically and/or cytologically confirmed stage I/II/III pancreatic cancer
* Full access to the patients' clinical and pathological records
* Ability to understand and the willingness to sign a written informed consent document
* 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 Criteria:

* Participants must not be pregnant or breastfeeding
* Participants must not have prior cancer histories or a second non-pancreatic 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 uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements or influence patient signing the written informed consent

Primary outcomes:
measure: Area under curve of the model for detecting stage I/II/III pancreatic cancer
timeFrame: 2 years
Secondary outcomes:
measure: Sensitivity of the early detection modell
timeFrame: 2 years
measure: Specificity of the early detection model
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Gao Chuntao
role: PRINCIPAL_INVESTIGATOR
References: