A Clinical Risk Score to Stratify High-risk PanNETs

NCT07695532 | Completed

• 1 other identifier: CSPAC-NEN-6
• Study Type: observational
• Target: 552
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neuroendocrine Tumors

Keywords

Pancreatic Neuroendocrine Tumors; High-risk; recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

  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 Outcomes (1)

• 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.

Study Arms (1)

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

Underwent curative surgical resection

Procedure: Curative surgical resection

Interventions

Curative surgical resection PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: collaborator
• IRCCS San Raffaele: collaborator
• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: June 1, 2017
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)