Using ctDNA methylation to guide prognosis and monitoring in pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a new CAR T-cell therapy for solid tumors expressing MSLN

  This study is testing a new CAR T-cell therapy to see if it can safely treat adults with solid tumors like colorectal and lung cancer that express a specific protein.

  Recruiting at 12 sites Phase 1/2 A2 Biotherapeutics Inc. · Gilbert, Arizona and 11 other locations · NCT06051695

• Liquid biopsy biomarkers to detect and monitor pancreatic cancer

  Researchers test blood-based microRNA signals to see if they can identify pancreatic cancer risk or early disease in people with familial or hereditary risk or mucinous cysts.

  Recruiting Università Vita-Salute San Raffaele · Milan, MI · NCT07700992

• INSPIRE: Putting patient-reported info into multidisciplinary tumor boards

  This study tests whether adding electronic patient-reported outcomes to tumor board discussions can help guide treatment decisions for women with breast, gynecologic, pancreatic cancers and related cancers.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama and 2 other locations · NCT07671937

• MRI scan for detecting pancreatic cancer in people at high risk

  This study tests a dedicated pancreas MRI (MRP) tool to see if it helps find pancreatic cancer earlier in people with a strong family or genetic risk.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07612046

• Cutting down ultra-processed foods for people at high cancer risk

  This project tests whether using the Open Food Facts smartphone app alongside nutrition education helps adults at high risk of cancer eat fewer ultra-processed foods.

  Recruiting at 2 sites Gustave Roussy, Cancer Campus, Grand Paris · Avignon and 2 other locations · NCT07436312

• Carbon nanoparticle‑loaded iron for advanced solid tumors

  This test uses direct injections of a carbon nanoparticle‑loaded iron medicine (CNSI‑Fe) to see if it can shrink tumors in adults with advanced solid cancers who have no effective standard treatment options.

  Recruiting at 4 sites Phase 1/2 Sichuan Enray Pharmaceutical Sciences Company · Beijing, Beijing Municipality and 8 other locations · NCT07433283

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.