MSCAN: ctDNA Methylation as Prognostic and Theranostic Tool for Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYingbin Liu, MD, PhD, FACS
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age range between 18 and 80 years old;
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;
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);
Ability to provide tumor tissue and blood samples;
Disqualifiers
Unable to provide tumor tissue and blood samples;
Previously received molecular targeted therapy, immunotherapy, or anti-tumor radiochemotherapy before this study;
History of malignancies other than pancreatic malignancy;
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);
Trial population
The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: benign
Group B: malignant
Trial outcomes
Primary outcomes
1
Sensitivity and Specificity of ctDNA in Early Screening for Pancreatic Cancer
Measured using a targeted DNA methylation panel for ctDNA in plasma. The presence or absence of cancer will be confirmed by histopathological diagnosis. Sensitivity and specificity will be calculated using standard diagnostic test evaluation against the gold-standard diagnosis. "Early-stage" is defined as stage I or II pancreatic cancer confirmed by imaging and pathology.
Time frame
Up to 2 years from start of study2
Sensitivity and Specificity of ctDNA Methylation Test for Detection of Postoperative Recurrence
Measured using plasma ctDNA methylation profiles collected at scheduled postoperative time points (e.g., every 3 months). Recurrence will be confirmed by imaging (CT/MRI) or biopsy when clinically indicated. Diagnostic accuracy (sensitivity/specificity) will be evaluated by comparing ctDNA results to confirmed recurrence status.
Time frame
Up to 2 years from start of studySecondary outcomes
1
Progression-Free Survival (PFS) Based on Imaging and Clinical Assessment
PFS will be calculated from the date of enrollment to the date of disease progression or death from any cause. Disease progression will be assessed using RECIST 1.1 criteria via CT/MRI scans performed every 3-6 months.
Time frame
Up to 3 years from start of study2
Overall Survival (OS)
Overall survival will be defined as the time from enrollment to death from any cause. Survival status will be monitored every 3 months through clinic visits or phone follow-up.
Time frame
Up to 3 years from start of study3
Early and Late Imaging Data
CT and/or MRI imaging will be used to measure tumor size, vascular invasion, and metastasis at baseline and every 3-6 months. Data will be used to assess tumor response, progression, or recurrence.
Time frame
Up to 3 years from start of study4
Levels of Serum Tumor Biomarkers (CA19-9, CEA) in Early-Stage Pancreatic Cancer
Serum levels of CA19-9 and CEA will be measured at baseline and during follow-up visits using standard immunoassays. Biomarker trends will be analyzed to assess correlation with disease stage, treatment response, and recurrence.
Time frame
Up to 3 years from start of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Yingbin Liu, MD, PhD, FACS
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor institution
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Ruijin Hospital
Collaborator
Changhai Hospital
Collaborator
Source ClinicalTrials.gov