Early Detection of Pancreatic Cancer

NCT ID: NCT05596435

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 496 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-10-12

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No intervention

Intervention Type: OTHER

No intervention

Pancreatic disease

Cell-free DNA collected from plasma samples of 80 patients with pancreatic benign disease will undergo whole-genome sequencing

No intervention

Intervention Type: OTHER

No intervention

Healthy controls

Cell-free DNA collected from plasma samples of 100 non-cancer individuals will serve as controls

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gao Chuntao

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gao Chuntao, MD

Role: CONTACT

gaochuntao@tjmuch.com

15822757365

Facility Contacts

Gao Chuntao

Role: primary

gaochuntao@tjmuch.com

15822757365

Other Identifiers

PANC-2022

Identifier Type: -

Identifier Source: org_study_id