Gastroenteropancreatic Neuroendocrine TumorDENUTNENCT07302100
Nutritional Status Assessment in Adult Patients Followed for Gastroenteropancreatic Neuroendocrine Tumors at Strasbourg University Hospital
An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Tumor reclassified as non-neuroendocrine by histopathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Endocrinologie, Diabétologie, Nutrition - CHU de Strasbourg - France
Strasbourg, 67091
Philippe BALTZINGER, MD, 33 3 88 12 75 82, philippe.baltzinger@chru-strasbourg.fr
Philippe BALTZINGER, MD
About this study
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.
Read more
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.
- Keywords
- Gastroenteropancreatic Neuroendocrine Tumor, Neuroendocrine tumors, Gastroenteropancreatic, Gastrointestinal
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a proportion of patients with malnutrition
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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start12 Dec 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302100
- Sponsor's protocol ID
- 9485
- Acronym
- DENUTNE
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Assessment in Adult Patients Followed for Gastroenteropancreatic Neuroendocrine Tumors at Strasbourg University Hospital
- ClinicalTrials.gov ID
- NCT07302100
- Acronym / sponsor ID
- DENUTNE / 9485
- Keywords
- Gastroenteropancreatic Neuroendocrine Tumor, Neuroendocrine tumors, Gastroenteropancreatic, Gastrointestinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Dec 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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Tumor reclassified as non-neuroendocrine by histopathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
Related trials for Gastroenteropancreatic Neuroendocrine Tumor
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
RecruitingPhase 2
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2
Enrolling by invitationObservational study
Liver Transplantation Versus Conventional Medical Therapy for Low-Grade GEP-NET With Liver Metastases
Neuroendocrine Tumors
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
Not yet recruitingPhase 3
TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Gastroenteropancreatic Neuroendocrine Tumors
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.
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 Gastroenteropancreatic Neuroendocrine Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Dec 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe BALTZINGER, MD (33 3 88 12 75 82, philippe.baltzinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a proportion of patients with malnutrition (time frame: Up to 12 months). 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 24 Dec 2025.