NCT06983106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2025

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

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).

    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

    From baseline CT to 10-year follow-up or death

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Zhen Li, Dr

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 21, 2025

Study Start

November 4, 2024

Primary Completion

December 30, 2024

Study Completion

March 29, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations