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NCT Number: NCT06941987

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

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.

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Key information

Conditions

Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplastic Processes Pancreatic Cancer Resectable Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  5. The correlation between serum markers and OS

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

  6. The diagnostic performance of NART detection

    Time frame: From the date of first enrollment until the study completion, an average of 30 months.

    Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse.

  7. The diagnostic performance of conventional ct-DNA test.

    Time frame: From the date of first enrollment until the study completion, an average of 30 months.

    Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse.

  8. The diagnostic performance of serum markers.

    Time frame: From the date of first enrollment until the study completion, an average of 30 months.

    Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenquan Wang

CONTACT

[email protected]

+86 21 31587861

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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