Clinical trial · Observational
Early Detection of Pancreatic Cancer
Early Detection of Pancreatic Cancer Using Plasma Cell-free DNA Fragmentomics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Stage I-III pancreatic cancer
- description
- Cell-free DNA collected from plasma samples of 260 patients with stage I-III pancreatic cancer will undergo whole-genome sequencing
- interventionNames
- Other: No intervention
- label
- Pancreatic disease
- description
- Cell-free DNA collected from plasma samples of 80 patients with pancreatic benign disease will undergo whole-genome sequencing
- interventionNames
- Other: No intervention
- label
- Healthy controls
- description
- Cell-free DNA collected from plasma samples of 100 non-cancer individuals will serve as controls
- interventionNames
- Other: No intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available