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A Clinical Risk Score to Stratify High-risk PanNETs

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07695532
Enrollment
552
Registered
2026-07-10
Start date
2017-06-01
Completion date
2026-07-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neuroendocrine Tumors

Keywords

Pancreatic Neuroendocrine Tumors, High-risk, recurrence

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;

Interventions

PROCEDURECurative surgical resection

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

Sponsors

Fudan University
Lead SponsorOTHER
West China Hospital
CollaboratorOTHER
IRCCS San Raffaele
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-free survival (RFS)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

MeasureTime frameDescription
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.Time from surgery to death from any cause. Patients alive at the time of last follow-up will be censored.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026