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CompletedNCT06983106GEP-NENsUpdated May 21, 2025

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

An observational study in Neuroendocrine Tumors, sponsored by Tongji Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Tongji Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
633
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Neuroendocrine Tumors

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In context

Neuroendocrine Tumors

682 studies on the registry are indexed under Neuroendocrine Tumors; 164 are open to participants now.

This study's enrollment of 633 is above the median of 117 across 175 observational studies indexed under Neuroendocrine Tumors.

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Lead sponsor

Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This retrospective multi-center study involved three separate medical centers. Data from April 2015 to April 2024 were obtained from the respective hospital information systems, with CT scan images retrieved from the Picture Archiving and Communication System. Patients were included based on the following criteria: (1) a confirmed diagnosis of GEP-NENs via histopathology with a WHO grading; (2) available enhanced CT scans that included full abdominal imaging before surgery or biopsy. The exclusion criteria were: (1) therapeutic interventions before surgery or biopsy; (2) poor image quality or incomplete CT images of the whole abdomen. The WHO grading was derived from the postoperative pathology reports, which were meticulously reviewed and certified by experienced senior pathologists.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
633 participants (actual)
Patient registry
No

Interventions

  • Otherbody composition calculate

    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.

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What researchers measure

Primary outcomes

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

    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).

    Time frame: Preoperative contrast-enhanced CT performed within one month before surgery

Secondary outcomes

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

    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.

    Time frame: From baseline CT to 10-year follow-up or death

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Study locations

1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
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References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 4, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06983106
Lead sponsor
Tongji Hospital
Responsible party
Zhen Li (Professor, Tongji Hospital) — Principal investigator
First posted
May 21, 2025
Start date
Nov 4, 2024
Primary completion
Dec 30, 2024
Completion
Mar 29, 2025
Last update
May 21, 2025

Study contacts

Zhen Li, Dr
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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