Clinical trial NCT06941987: Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
Official title: Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Minimal Residual Disease
Pancreatic Cancer Resectable
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receive radical resection without naoadjuvant therapy and diganosed pancreatic ductal adenocarcinoma pathologically are eligible.

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.


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

Primary outcomes:
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:
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
measure: The correlation between conventional ct-DNA test and OS
timeFrame: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
measure: The correlation between serum markers and OS
timeFrame: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
measure: The diagnostic performance of NART detection
timeFrame: From the date of first enrollment until the study completion, an average of 30 months.
measure: The diagnostic performance of conventional ct-DNA test.
timeFrame: From the date of first enrollment until the study completion, an average of 30 months.
measure: The diagnostic performance of serum markers.
timeFrame: From the date of first enrollment until the study completion, an average of 30 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Shanghai
Study officials:
References: