Clinical trial NCT06983106: Correlation Between Body Composition and Pathologic Grade/Prognosis in GEP-NENs: A Retrospective Study
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 633
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between CT-measured abdominal fat index(cm3/m3) and pathological grade (WHO classification) in GEP-NENs
timeFrame: Preoperative contrast-enhanced CT performed within one month before surgery
Secondary outcomes:
measure: Correlation between CT-measured abdominal fat index(cm3/m3) and 10-year overall survival (days) in GEP-NENs
timeFrame: From baseline CT to 10-year follow-up or death
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zhen Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: