Using ctDNA methylation to guide prognosis and monitoring in pancreatic cancer
Methylation Signature of Circulating Tumour DNA as a Prognostic and Theranostic Tool for Managing Pancreatic Ductal Adenocarcinoma
This project tests whether a blood test that measures ctDNA methylation can help detect and monitor pancreatic cancer in adults who are undergoing surgery or biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07045571 on ClinicalTrials.gov |
What this trial studies
The study will perform whole-genome methylation scans on tumor tissue and matched blood samples to identify tumor-specific methylation sites. Investigators will then design a targeted sequencing panel to measure those methylation markers in circulating tumor DNA (ctDNA) from plasma. Collected data will be used to build an intelligent diagnostic and dynamic monitoring model for early detection and postoperative surveillance. The approach emphasizes a minimally invasive liquid biopsy that may detect methylation changes earlier or more frequently than mutation-based assays.
Who should consider this trial
Good fit: Adults aged 18–80 with a pancreatic mass suspicious for malignancy who are scheduled for surgical resection or tissue biopsy, have ECOG 0–1, and can provide blood and tumor tissue samples are ideal candidates.
Not a fit: People without measurable pancreatic lesions, those unable to provide tissue or blood samples, or patients with poor organ function or non-PDAC diagnoses are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could enable earlier, less invasive detection and better postoperative monitoring of pancreatic cancer, potentially improving outcomes.
How similar studies have performed: Prior research on ctDNA methylation panels in pancreatic and other cancers has shown promising early results, suggesting methylation can be a sensitive early marker, but large-scale clinical validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients meeting all inclusion criteria are eligible to enter this study, including but not limited to: 1. Age range between 18 and 80 years old; 2. Identification of pancreatic space-occupying lesions through imaging examinations, with a high suspicion of pancreatic malignant tumors and planned for surgical treatment or tissue biopsy for pathological confirmation; 3. According to RECIST 1.1 evaluation criteria, having at least one measurable lesion (the longest diameter of the target lesion on spiral CT scan ≥10mm); 4. Ability to provide tumor tissue and blood samples; 5. Stable vital signs, ECOG score of 0-1; 6. Liver function with AST and ALT ≤ 5 times the upper limit of normal (ULN), Child-Pugh classification of A or B; white blood cell count \> 3×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L; platelets ≥ 75×10\^9/L; hemoglobin ≥ 90g/L; creatinine clearance rate ≥ 60ml/min; total bilirubin ≤ 3 times ULN; 7. Reproductive-age patients and their spouses willing to adopt contraceptive measures; female patients must undergo a pregnancy test (serum or urine) within 7 days before enrollment with a negative result. 8. Voluntarily participate in this experimental project, patients with good compliance; if the subject is unable to read or sign, the informed consent form must be signed by a legal representative with the subject's informed consent, and for subjects incapable of expressing consent, the introduction and explanation shall be provided to their legal representative, who will then sign the informed consent form. Exclusion Criteria: Patients meeting any of the exclusion criteria will not be eligible for inclusion, including but not limited to: 1. Unable to provide tumor tissue and blood samples; 2. Previously received molecular targeted therapy, immunotherapy, or anti-tumor radiochemotherapy before this study; 3. History of malignancies other than pancreatic malignancy; 4. Presence of other severe diseases, including but not limited to uncontrolled congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to severe hypertension (SBP \> 160mmHg or DBP \> 100mmHg); 5. Uncontrolled diabetes; 6. Active infection; 7. Patients with active autoimmune diseases requiring long-term use of steroids; 8. Patients who have undergone allogeneic transplantation; 9. Active psychiatric disorders affecting informed consent and/or protocol compliance; 10. Other severe illnesses deemed inappropriate for participation in this study by investigators.
Where this trial is running
Shanghai, Shanghai Municipality
- Renji hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yinbin Liu, PhD — RenJi Hospital
- Study coordinator: Yinbin Liu, PhD
- Email: laoniulyb@163.com
- Phone: +86 13918803900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.