RECRUITINGOBSERVATIONAL
MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer
Methylation Signature of Circulating Tumour DNA as a Prognostic and Theranostic Tool for Managing Pancreatic Ductal Adenocarcinoma
About This Trial
Developing a characteristic ctDNA methylation panel for pancreatic ductal adenocarcinoma and establishing an intelligent diagnostic and dynamic monitoring model based on ctDNA methylation.
Who May Be Eligible (Plain English)
Who May Qualify:
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; platelet count at least 75×10\^9/L; blood count (hemoglobin) at least 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 willing to sign a consent form form must be signed by a legal representative with the subject's willing to sign a consent form, and for subjects incapable of expressing consent, the introduction and explanation shall be provided to their legal representative, who will then sign the willing to sign a consent form form.
Who Should NOT Join This Trial:
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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Locations (1)
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China