Minimal Residual Disease, Pancreatic Cancer Resectable
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 * Assessd as resectable PDAC before surgical procedure * Voluntary to donate tumor samples resected in curative surgery for PDAC * Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol * ECOG state (PS) grades ≤ 2 * Voluntary to sign informed consent and adhering to the requirements and limitations outlined by lCD and this protocol * Confimed as pancreatic ductal adenocarcinoma by pathology * RO or R1 resection * Clinically evalutated eligible for adjuvant therapy * Tumor tissue samples meet the requirements of whole exome sequencing (WES)
Exclusion criteria
* Preoperative imaging examinations show distant metastasis * Have received neoadjuvant therapy * Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee * With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities * Have participated in other interventional or observational clinical studies
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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 diagnostic performance of NART detection | From the date of first enrollment until the study completion, an average of 30 months. | 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. |
| The diagnostic performance of conventional ct-DNA test. | From the date of first enrollment until the study completion, an average of 30 months. | 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. |
| The diagnostic performance of serum markers. | From the date of first enrollment until the study completion, an average of 30 months. | 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. |
| The correlation between serum markers and OS | From date of surgery until the date of death, assessed 3 months thereafter up to 60 months | — |
Countries
China
Contacts
Primary ContactWenquan Wang
Outcome results
None listed