Clinical trial · Observational
Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
NCT06941987CI-TRIAL-00088844not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Minimal Residual Disease | — | UNRESOLVED | — |
| Pancreatic Cancer Resectable | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The correlation between NART detection and recurrence-free survival
- timeFrame
- From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
Secondary outcomes (8)
- measure
- The correlation between conventional ct-DNA test and RFS
- timeFrame
- From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
- measure
- The correlation between serum markers and RFS
- timeFrame
- From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
- measure
- The correlation between NART detection and overall survival (OS)
- timeFrame
- From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.