Status:
NOT_YET_RECRUITING
Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Minimal Residual Disease
Pancreatic Cancer Resectable
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 20 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06941987
Start Date
April 20 2025
End Date
October 20 2027
Last Update
April 24 2025
Active Locations (1)
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1
Zhongshan Hospital, Shanghai
Shanghai, China