Neuroendocrine TumorsGEP-NENsNCT06983106
Correlation Between Body Composition and Pathologic Grade/Prognosis in GEP-NENs: A Retrospective Study
An observational study of Neuroendocrine Tumors, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- body composition calculate
- How many people
- 633 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 29 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Therapeutic interventions before surgery or biopsy
- Poor image quality or incomplete CT images of the whole abdomen
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this 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
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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- body composition calculate
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body composition calculateOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From baseline CT to 10-year follow-up or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start4 Nov 2024
- Primary completion30 Dec 2024
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Li, Tongji Hospital
- Investigators
- Zhen Li, Dr, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983106
- Sponsor's protocol ID
- TJ-IRB202411010
- Acronym
- GEP-NENs
- Status last verified
- May 2025
- First submitted
- 21 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06983106
- Acronym / sponsor ID
- GEP-NENs / TJ-IRB202411010
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Therapeutic interventions before surgery or biopsy
- Poor image quality or incomplete CT images of the whole abdomen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body composition calculateThe 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. | Other | – |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Li, Dr principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.