Risk Factors, Prognosis, Clinicopathological and Metabolic Characteristics of EO- vs LO-PanNETs

NCT07136701 | Not Yet Recruiting

• 1 other identifier: KYLL-2025-07-004
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational multicenter retrospective cohort study is to evaluate the differences in risk factors, prognosis, clinicopathological and metabolic characteristics between early-onset pancreatic neuroendocrine tumors (EO-PanNETs) and late-onset pancreatic neuroendocrine tumors (LO-PanNETs). The main questions it aims to answer are: Are there distinct clinical, pathological, and metabolic profiles in EO-PanNETs compared with LO-PanNETs? Do EO-PanNETs have different prognostic outcomes compared with LO-PanNETs? Researchers will compare EO-PanNET patients with LO-PanNET patients and with matched nonmalignant controls to assess differences in tumor characteristics and associated metabolic conditions. Participants will: Provide retrospective clinical, pathological, and metabolic data from hospital records. Have survival and recurrence outcomes assessed through follow-up data review.

Conditions

Pancreatic Neuroendocine Neoplasms (pNETs)

Keywords

EO-PanNET

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From date of randomization until the date of death from any cause or the date of the last follow-up, whichever came first, assessed up to 12 years

Secondary Outcomes (3)

• Disease-specific survival

  From date of diagnosis until death due to PanNETs, up to 12 years

• Progression-free survival

  From date of diagnosis until the date of disease recurrence or death from any cause, whichever came first, assessed up to 12 years.

• Disease-free survival

  From date of surgery until first documented recurrence, metastasis, or death from any cause, assessed up to 12 years.

Study Arms (2)

Early-onset pancreatic neuroendocrine tumors group

This group comprises patients diagnosed with pancreatic neuroendocrine tumors before the age of 50 years. All cases were histopathologically confirmed and treated at one of the participating centers.

Late-onset pancreatic neuroendocrine tumors group

This group comprises patients diagnosed with pancreatic neuroendocrine tumors at or after the age of 50 years. All cases were histopathologically confirmed and treated at one of the participating centers.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprised adult patients (≥18 years) diagnosed with pancreatic neuroendocrine tumors (PanNETs) between 2013 and 2024. All cases had a histopathologically confirmed diagnosis and received treatment at one of the participating centers. Patients were excluded if they had poorly differentiated neuroendocrine carcinoma, mixed neuroendocrine-non-neuroendocrine neoplasm, undefined tumor differentiation, recurrent disease, non-initial treatment, or a history of other malignancies.

You may qualify if:

• years or older; histopathologically confirmed pancreatic neuroendocrine tumor by surgical resection or biopsy.

You may not qualify if:

• Pancreatic neuroendocrine carcinoma; incomplete pathological data; received antitumor treatment prior to presentation; with other malignanies or malignant history.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• China-Japan Friendship Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Central Study Contacts

Hanxiang Zhan, MD. PhD.

CONTACT

+86 18560085156; zhanhanxiang@hotmail.com

Changhao Gao, MMed

CONTACT

gaochanghao44@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Pancreatic Surgery

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)