Nutritional Status Assessment in Adult Patients Followed for Gastroenteropancreatic Neuroendocrine Tumors at Strasbourg University Hospital (DENUTNE)

December 11, 2025 updated by: University Hospital, Strasbourg, France

Neuroendocrine tumors represent a heterogeneous group of tumors, of which gastrointestinal (gastroenteropancreatic) NETs are the most frequent.

Therapeutic management involves several approaches: control of any secretory syndrome and tumor control. Surgery is the first-line treatment for localized stages. When there is distant metastasis, various systemic treatments can be combined or administered sequentially (somatostatin analogs, everolimus, sunitinib, radioablation, targeted internal radiotherapy, cytotoxic chemotherapy). Gastrointestinal NETs are most often well-differentiated and slow-growing tumors with a median overall survival of up to 9 years (all sites combined), making comprehensive management of these patients all the more important.

In the context of cancer management, malnutrition has been shown to be associated with a poorer prognosis. Similarly, addressing malnutrition and improving nutritional parameters have been associated with improved prognosis.

The impact of nutritional status in patients with slow-growing tumors such as gastrointestinal neuroendocrine tumors (NETs) is less well understood but could be a modifiable factor for improving quality of life and treatment efficacy.

The research hypothesis is that nutritional status is associated with the prognosis of patients with gastrointestinal NETs.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Endocrinologie, Diabétologie, Nutrition - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Philippe Baltzinger, MD
        • Principal Investigator:
          • Marine HUITOREL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 to 70 years being monitored for a digestive neuroendocrine tumor (gastric, pancreatic, intestinal), diagnosed between January 1, 2000, and November 30, 2024

Description

Inclusion Criteria:

  • Adults aged 18 to 70 years
  • Patients being monitored for a digestive neuroendocrine tumor (gastric, pancreatic, intestinal), diagnosed between January 1, 2000, and November 30, 2024

Exclusion Criteria:

- Tumor reclassified as non-neuroendocrine by histopathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a proportion of patients with malnutrition
Time Frame: Up to 12 months

The proportion of patients with malnutrition based on weight loss, compared to usual weight before the onset of illness, is distributed as follows:

  • weight loss ≥ 5% in 1 month or
  • weight loss ≥ 10% in 6 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9485

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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