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The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. The main question it aims to answer is: Is NART a sensitive and accurate detection for MRD? Participants are required to undergo periodic blood sampling and imaging examinations as the protocol specifies.
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| Measure | Description | Time Frame |
|---|---|---|
| The correlation between NART detection and recurrence-free survival | From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation between conventional ct-DNA test and RFS | From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months | |
| The correlation between serum markers and RFS | From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receive radical resection without naoadjuvant therapy and diganosed pancreatic ductal adenocarcinoma pathologically are eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenquan Wang | Contact | +86 21 31587861 | wang.wenquan@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Shanghai | Shanghai | China |
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| The correlation between NART detection and overall survival (OS) | From date of surgery until the date of death, assessed 3 months thereafter up to 60 months |
| The correlation between conventional ct-DNA test and OS | From date of surgery until the date of death, assessed 3 months thereafter up to 60 months |
| The correlation between serum markers and OS | From date of surgery until the date of death, assessed 3 months thereafter up to 60 months |
| The diagnostic performance of NART detection | Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse. | From the date of first enrollment until the study completion, an average of 30 months. |
| The diagnostic performance of conventional ct-DNA test. | Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse. | From the date of first enrollment until the study completion, an average of 30 months. |
| The diagnostic performance of serum markers. | Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse. | From the date of first enrollment until the study completion, an average of 30 months. |
| ID | Term |
|---|---|
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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