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

NCT06941987 | Not Yet Recruiting

• 1 other identifier: ZSPAC-11
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• The correlation between conventional ct-DNA test and RFS

  From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months

• The correlation between serum markers and RFS

  From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months

• The correlation between NART detection and overall survival (OS)

  From date of surgery until the date of death, assessed 3 months thereafter up to 60 months

• The correlation between conventional ct-DNA test and OS

  From date of surgery until the date of death, assessed 3 months thereafter up to 60 months

• The correlation between serum markers and OS

  From date of surgery until the date of death, assessed 3 months thereafter up to 60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receive radical resection without naoadjuvant therapy and diganosed pancreatic ductal adenocarcinoma pathologically are eligible.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenquan Wang

CONTACT

+86 21 31587861; wang.wenquan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 24, 2025
• Study Start: April 20, 2025
• Primary Completion: October 20, 2025
• Study Completion (Estimated): October 20, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)