NCT07045571 MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer
| NCT ID | NCT07045571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yingbin Liu, MD, PhD, FACS |
| Condition | Pancreatic Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-10-30 |
| Primary Completion | 2026-01-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-10-30 with a primary completion date of 2026-01-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.
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.
Contact & Investigator
Yinbin Liu, PhD
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT07045571 clinical trial?
This trial is open to participants of all sexes, studying Pancreatic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07045571 currently recruiting?
Yes, NCT07045571 is actively recruiting participants. Contact the research team at laoniulyb@163.com for enrollment information.
Where is the NCT07045571 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07045571 clinical trial?
NCT07045571 is sponsored by Yingbin Liu, MD, PhD, FACS. The principal investigator is Yinbin Liu, PhD at RenJi Hospital. The trial plans to enroll 1,000 participants.