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Completed

NCT Number: NCT07695532

A Clinical Risk Score to Stratify High-risk PanNETs

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.

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Key information

Conditions

Pancreatic Neuroendocrine Tumors Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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;

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Curative surgical resection

Procedure

After pathological confirmation of pancreatic neuroendocrine neoplasm, the patient underwent radical surgery.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • IRCCS San Raffaele
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

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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