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NCT Number: NCT07302100

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Endocrinologie, Diabétologie, Nutrition - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Marine HUITOREL, MD

PRINCIPAL_INVESTIGATOR

Philippe BALTZINGER, MD

CONTACT

[email protected]

33 3 88 12 75 82

Philippe BALTZINGER, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe BALTZINGER, MD

CONTACT

[email protected]

33 3 88 12 75 82

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: DENUTNE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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