Evaluate The Clinical Feasibility Of A Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology For Postoperative MRD Surveillance Of Pancreatic Cancer

Study Overview

Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer

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.

N/A

Minimal Residual Disease
Pancreatic Cancer Resectable

ZSPAC-11

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-19
First Submitted that Met QC Criteria 2025-04-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-24
First Posted (ACTUAL) 2025-04-24	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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

Secondary Outcome Measures	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
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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wenquan Wang

Phone Number: +86 21 31587861

Email: wang.wenquan@zs-hospital.sh.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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