Correlation Between Body Composition and Pathologic Grade/Prognosis in GEP-NENs: A Retrospective Study

Completed

• Conditions: Neuroendocrine Tumors

• Registration Number: NCT06983106
• Lead Sponsor: Tongji Hospital

Brief Summary

The goal of this observational study is to learn about the value of body composition as predictors of pathological grading and prognosis in patients with gastroenteropancreatic neuroendocrine neoplasms.

The main question it aims to answer is: Does body composition affect the pathological grading and prognosis of patients with gastroenteropancreatic neuroendocrine tumors? Participants with gastroenteropancreatic neuroendocrine neoplasms will answer questions about their physical condition during follow-up visits.

Detailed Description

Objectives To explore the value of body composition parameters (BCPs) as predictors of pathological grading, prognosis in patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs).

Methods This retrospective multicenter analysis enrolled GEP-NENs patients pathologically confirmed from three institutions between 2015 and 2024. The volume of skeletal muscle and abdominal fat tissue was calculated based on CT scans at diagnosis. Univariate and multivariate logistic regression analyses were used to identify the relationships between BCPs and the pathological grade. The Kaplan-Meier method, along with the log-rank test, was employed for survival analysis. Independent prognostic factors were identified through uni- and multivariable Cox regression analyses.

Study Timeline

• Study Start: 2024-11-04
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-29
• Study First Submitted: 2025-04-21
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

Inclusion Criteria

• A confirmed diagnosis of GEP-NENs via histopathology with a WHO grading
• Available enhanced CT scans that included full abdominal imaging before surgery or biopsy

Exclusion Criteria

• Therapeutic interventions before surgery or biopsy
• Poor image quality or incomplete CT images of the whole abdomen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between CT-measured abdominal fat index(cm3/m3) and pathological grade (WHO classification) in GEP-NENs	Preoperative contrast-enhanced CT performed within one month before surgery	Quantify abdominal visceral fat index(cm3/m3) ,subcutaneous fat index(cm3/m3) and intermuscular fat index(cm3/m3) using preoperative contrast-enhanced CT, and analyze their Pearson correlation coefficient with pathological grade (WHO classification: G1, G2, G3).

Secondary Outcome Measures

Name	Time	Method
Correlation between CT-measured abdominal fat index(cm3/m3) and 10-year overall survival (days) in GEP-NENs	From baseline CT to 10-year follow-up or death	Quantify abdominal visceral fat index(cm3/m3) ,subcutaneous fat index(cm3/m3) and intermuscular fat index(cm3/m3) via preoperative CT, and analyze its Spearman correlation with overall survival (days from diagnosis to death) and progression-free survival (days from diagnosis to progression) using adjusted Cox proportional hazards models.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China