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

ConditionsMinimal Residual DiseasePancreatic Cancer Resectable
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The correlation between NART detection and recurrence-free survival

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

Secondary outcomes

1

The correlation between conventional ct-DNA test and RFS

Time frame
From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
2

The correlation between serum markers and RFS

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

The correlation between NART detection and overall survival (OS)

Time frame
From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
4

The correlation between conventional ct-DNA test and OS

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: