A Clinically Applicable Risk Score for Identifying High-risk Pancreatic Neuroendocrine Tumors: Development, Validation, and Biological Correlates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 552
- Locations
- 1
- Primary Endpoint
- Recurrence-free survival (RFS)
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Overall survival (OS)(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.)
Investigators
Xian-Jun Yu
President of Fudan University Shanghai Cancer Center
Fudan University