Early Detection of Pancreatic Cancer

Trial Title: Early Detection of Pancreatic Cancer

NCT ID: NCT05596435

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: No intervention
Description: No intervention
Arm group label: Healthy controls
Arm group label: Pancreatic disease
Arm group label: Stage I-III pancreatic cancer

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.

Criteria for eligibility:

Study pop:
Approximately 260 stage I/II/III gastric cancer patients, 70 patients with pancreatic benign diseases and 150 non-cancer controls

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Tianjin Medical University Cancer Institute and Hospital

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Gao Chuntao

Phone: 15822757365
Email: gaochuntao@tjmuch.com

Start date: October 10, 2022

Completion date: October 12, 2024

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05596435