A Clinical Risk Score to Stratify High-risk PanNETs

July 8, 2026 updated by: Xian-Jun Yu, Fudan University

A Clinically Applicable Risk Score for Identifying High-risk Pancreatic Neuroendocrine Tumors: Development, Validation, and Biological Correlates

Considerable heterogeneity exists in the risk of recurrence after curative resection of pancreatic neuroendocrine tumors (PanNETs). Current clinicopathological parameters (e.g., grade, TNM stage) have limited capacity for individualized risk stratification. There is an urgent need for a clinically accessible and operationally simple predictive tools to identify high-risk PanNETs for optimizing personalized postoperative treatment and follow-up strategies. This study aims to identify risk factors associated with recurrence of PanNETs and to develop a clinically applicable risk stratification tool based on multi-center cohorts and multi-omics validation for identifying high-risk patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To identify risk factors associated with recurrence after curative resection of PanNETs; To develop a predictive tool for recurrence of PanNETs based on routine clinicopathological features; To evaluate and validate the discriminative ability, calibration, and clinical benefit of the predictive tool; To perform biological validation of the predictive tool;

Study Type

Observational

Enrollment (Actual)

552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1).

Description

Inclusion Criteria:

- Pathologically confirmed PanNETs; Underwent curative surgical resection (R0 or R1); Complete clinicopathological data (see detailed variable list); Complete postoperative follow-up data.

Exclusion Criteria:

- Received neoadjuvant therapy before surgery; Hereditary PanNETs or pancreatic neuroendocrine carcinoma (PNEC); Distant metastasis before surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1)
Underwent curative surgical resection
Procedure: Curative surgical resection
After pathological confirmation of pancreatic neuroendocrine neoplasm, the patient underwent radical surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival (RFS)
Time Frame: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.
Time from surgery to first evidence of locoregional recurrence or distant metastasis confirmed by imaging or pathology
From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.
Time from surgery to death from any cause. Patients alive at the time of last follow-up will be censored.
From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

IRCCS San Raffaele
West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

July 1, 2026

Study Completion (Actual)

July 1, 2026

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-NEN-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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