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NCT Number: NCT06983106

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

body composition calculate

Other

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 volume of abdominal skeletal muscle and fat tissue is calculated based on CT scans at diagnosis.

Primary outcomes

  1. Correlation between CT-measured abdominal fat index(cm3/m3) and pathological grade (WHO classification) in GEP-NENs

    Time frame: 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 outcomes

  1. Correlation between CT-measured abdominal fat index(cm3/m3) and 10-year overall survival (days) in GEP-NENs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Value of Automatically Segmented Three-Dimensional(3D) Volumetric Body Composition in Predicting the Pathological Grading and Prognosis of Gastroenteropancreatic Neuroendocrine Neoplasms: A Multicenter Study

Acronym: GEP-NENs

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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