MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer

Launched by YINGBIN LIU, MD, PHD, FACS · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help diagnose and monitor pancreatic cancer by looking at tiny bits of DNA that come from the tumor and float in the blood. The researchers are developing a test that checks for specific changes in this DNA, called methylation, which could give doctors useful information about the cancer’s behavior and how well treatments are working over time.

Adults between 18 and 80 years old who have a suspicious lump in the pancreas, confirmed or planned to be confirmed by tissue biopsy or surgery, may be eligible to join. Participants need to have at least one tumor that can be measured on a CT scan and be in generally stable health with normal or near-normal liver, kidney, and blood function. If you join, you will provide samples of your tumor tissue and blood to help develop and test this new monitoring method. The study is currently looking for volunteers and aims to improve how pancreatic cancer is diagnosed and tracked during treatment.

Gender

ALL

Eligibility 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.