Ireland
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Starting soon Observational

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

NCT06941987 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-04-20
Last updated
2025-04-24

Condition(s) studied

Minimal Residual DiseasePancreatic Cancer Resectable

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Shanghai Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06941987 on ClinicalTrials.gov ↗ ← All trials in China