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

NCT ID: NCT06941987

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2027-10-20

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 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

Minimal Residual Disease; Pancreatic Cancer Resectable

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, Shanghai

Shanghai, , China

Countries

China

Central Contacts

Wenquan Wang

Role: CONTACT

wang.wenquan@zs-hospital.sh.cn

+86 21 31587861

Facility Contacts

Wen-Quan Wang

Role: primary

wang.wenquan@zs-hospital.sh.cn

+86 21 31587861

Other Identifiers

ZSPAC-11

Identifier Type: -

Identifier Source: org_study_id