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

Fudan University

Status: Not yet enrolling

Conditions: Pancreatic Cancer Resectable; Minimal Residual Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06941987

ZSPAC-11

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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