Gastroenteropancreatic Neuroendocrine TumorNUTRIGETNENCT04986085

Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by Grupo Espanol de Tumores Neuroendocrinos at 16 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastroenteropancreatic Neuroendocrine Tumor
How many people: 399 participants
Where: 16 sitesSpain
Study dates: 24 Feb 2021to 23 Feb 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
Adult, Older adult

Study population: Adult patients with gastroenteropancreatic neuroendocrine tumors diagnosed histologically that are on active treatment for the disease in Spain

Who may be able to join

Patients diagnosed with a gastroenteropancreatic neuroendocrine tumor by histopathological study.
Legally capable patients ≥ 18 and ≤ 80 years of age.
Patients who have signed the informed consent for this study as specified in section 10.3.
Patients in active treatment: active treatment is considered to be those patients in an advanced stage and in any type of medical treatment (somatostatin analogues, molecular therapies, chemotherapy, radionuclides...), or locoregional therapies.
Note: Decision was taken to treat the patient with an specific treatment prior and independently of patient inclusion in this non interventional study.

Who cannot join

Patients <18 or > 80 years of age.
Female patients that are currently pregnant.
Patients with a gastroenteropancreatic neuroendocrine tumor lacking an histopathological diagnosis.
Patients in palliative treatment or terminal stage.
Patients who have not signed the informed consent or any situation or condition that compromises the giving of patient voluntary informed consent.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Spain16 sites

Hospital Universitario Vall d´Hebron
Barcelona, 08035
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario de Cabueñes
Gijón, 33394
Hospital Universitario Dr. Josep Trueta
Girona, 17007
Hospital Universitario la Princesa
Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario la Paz
Madrid, 28046
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706
Hospital Universitari i Poliècnic la Fe
Valencia, 40026
Institut Valencià d'Oncologia (IVO)
Valencia, 46009
Hospital Universitario Miguel Servet
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Nutritional Status of Patients With Gastroenteropancreatic Neuroendocrine Tumors in Spain: NUTRIGETNE

It is well known that the prevalence of malnutrition or risk of malnutrition in cancer patients is high, as well as its impact on different parameters such as hospitalization, survival or response to certain treatments. In patients with gastroenteropancreatic (GEP) neuroendocrine tumors (NET), due to their heterogeneity and longer survival, it is expected that the prevalence of malnutrition is probably underdiagnosed, as well as the existence of a negative impact on different parameters (quality of life, survival). So far, the studies carried out on nutrition and NET are very scarce and none has been carried out so far in Spain.

Before being able to carry out nutritional intervention studies on these patients, it is necessary to know the reality of the nutritional status of patients with NETs in Spain. The main motivation for the NUTRIGETNE study is to evaluate the epidemiological status of nutrition in NETs in the spanish population. In addition to know the epidemiological picture, it is intended to study the nutritional status from different points of view: analytical, clinical, anthropometric, etc. Besides, the study of nutritional status will allow us to closely monitor the patients who have a higher risk of malnutrition and to propose early interventions for those, as well as the impact of their nutritional status on different parameters: survival, hospitalization, quality of life or responses to the treatments.

NUTRIGETNE is a cross-sectional, open and multicenter study in which the nutritional status of patients with GEP NET in Spain will be evaluated.

Read the detailed description

NUTRIGETNE is a cross-sectional, open and multicenter study in which the nutritional status of patients with GEP NET in Spain will be evaluated. It is planned to include 400 GEP NET patients. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization.

The study comprises 3 stages with a total duration of 10 to 40 days for the participation of each subject in the study:

Screening visit, First day (day 0): The initial screening will take place on the first day the patient visits the hospital. The inclusion and exclusion criteria will be reviewed to assess the eligibility of the patient. The implications of the study will be explained to the patient and the informed consent will be signed.

Visit for assessment of nutritional status (days 0-10): taking a medical history, complete physical examination including anthropometry, bioelectrical impedance (BIA) and dynamometry, as well as laboratory analysis. The evaluation of the nutritional status will be carried out by a registered nutritionist, specialized nurse or specialist doctor (variable depending on the characteristics of the center).

Data collection (day 10-40): collection of analytical, anthropometric, BIA, dynamometry and clinical results and introduction into the electronic case report form (eCRF).

After the end of recruitment and database lock, all data will be subsequently analyzed and presented when applicable through study reports and scientific communications.

Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Keywords: GEP NET, Neuroendocrine tumor, Nutritional status
Medical subject headings: Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04986085
Study group	Role	What they receive
GEP NET		GEP NET patients in Spain

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of Malnutrition in GEP NET
Percentage of GEP NET patients suffering from malnutrition in Spain according to the Global Leadership Initiative on Malnutrition (GLIM), which was convened by several of the major global clinical nutrition societies. Malnutrition diagnosis is based on three phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and two etiologic criteria (reduced food intake or assimilation, and inflammation or disease burden). Patients having one or more phenotypic and etiologic criteria are considered malnourished.
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Risk of Malnutrition in GEP NET
Percentage of GEP NET patients at risk of suffering from malnutrition in Spain according to Malnutrition Universal Screening Tool (MUST). Three independent criteria are used by MUST to determine the overall risk for malnutrition: current weight status using BMI, unintentional weight loss, and acute disease effect.
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)

Secondary outcomes (5)

Body Mass Index
Body mass index (BMI) is defined as a a measure of body fat based on height and weight that applies to adult men and women
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Body Fat
Body fat mass calculated by bioimpedance
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Phase Angle
Body muscle mass calculated by bioimpedance and measured by Phase Angle. Here we report the phase angle, a marker of muscle mass and function, measured in degrees. Higher degrees of phase angle indicates greater cell integrity and function, reflecting healthier and more robust muscles.
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Nutritional Risk Screening (NRS) Rates
Scale to evaluate the malnutrition in adult patients. It is based in the assessment of BMI, weight loss in the last 3-6 months and acute disease effects. The score ranges from 0 (low malnutrition risk to 6 (high malnutrition risk).
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Subjective Global Assessment (SGA) Rates
Score to measure risk malnutrition in adult patients based on patient history and physical examination alone. The score has 3 levels: A (low malnutrition risk) to C (high malnutrition risk)
Measured: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202123 Feb 2024

First posted2 Aug 2021
Study start24 Feb 2021
Primary completion23 Jan 2024
Study completion23 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies 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: Ecologic or community
Time perspective: Cross-sectional
Enrolment: 399 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04986085
Sponsor's protocol ID: GETNE-S2109
Acronym: NUTRIGETNE
Status last verified: Mar 2025
First submitted: 22 Mar 2021
Last updated: 28 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Gastroenteropancreatic Neuroendocrine Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nutritional Status of Patients With Gastroenteropancreatic Neuroendocrine Tumors in Spain: NUTRIGETNE
ClinicalTrials.gov ID: NCT04986085
Acronym / sponsor ID: NUTRIGETNE / GETNE-S2109
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Keywords: GEP NET, Neuroendocrine tumor, Nutritional status
Study type: Observational
Recruitment status: Completed
Enrolment: 399 participants (actual)
Lead sponsor: Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
Study start: 24 Feb 2021 (actual)
Primary completion: 23 Jan 2024 (actual)
Study completion: 23 Feb 2024 (actual)
First posted: 2 Aug 2021 (actual)
Results: Posted 28 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

NUTRIGETNE is a cross-sectional, open and multicenter study in which the nutritional status of patients with GEP NET in Spain will be evaluated.

Detailed description

The study comprises 3 stages with a total duration of 10 to 40 days for the participation of each subject in the study:

Data collection (day 10-40): collection of analytical, anthropometric, BIA, dynamometry and clinical results and introduction into the electronic case report form (eCRF).

After the end of recruitment and database lock, all data will be subsequently analyzed and presented when applicable through study reports and scientific communications.

Study design

Observational model: Ecologic or community
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
GEP NET	–	–GEP NET patients in Spain

Who may qualify

Ages: 18 to 80 years
Sex: All
Age groups: Adult, Older adult
Study population: Adult patients with gastroenteropancreatic neuroendocrine tumors diagnosed histologically that are on active treatment for the disease in Spain

Key inclusion criteria (5 listed)

Patients diagnosed with a gastroenteropancreatic neuroendocrine tumor by histopathological study.
Legally capable patients ≥ 18 and ≤ 80 years of age.
Patients who have signed the informed consent for this study as specified in section 10.3.
Patients in active treatment: active treatment is considered to be those patients in an advanced stage and in any type of medical treatment (somatostatin analogues, molecular therapies, chemotherapy, radionuclides...), or locoregional therapies.
Note: Decision was taken to treat the patient with an specific treatment prior and independently of patient inclusion in this non interventional study.

Key exclusion criteria (5 listed)

Patients <18 or > 80 years of age.
Female patients that are currently pregnant.
Patients with a gastroenteropancreatic neuroendocrine tumor lacking an histopathological diagnosis.
Patients in palliative treatment or terminal stage.
Patients who have not signed the informed consent or any situation or condition that compromises the giving of patient voluntary informed consent.

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

Prevalence of Malnutrition in GEP NET
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Percentage of GEP NET patients suffering from malnutrition in Spain according to the Global Leadership Initiative on Malnutrition (GLIM), which was convened by several of the major global clinical nutrition societies. Malnutrition diagnosis is based on three phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and two etiologic criteria (reduced food intake or assimilation, and inflammation or disease burden). Patients having one or more phenotypic and etiologic criteria are considered malnourished.
Risk of Malnutrition in GEP NET
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Percentage of GEP NET patients at risk of suffering from malnutrition in Spain according to Malnutrition Universal Screening Tool (MUST). Three independent criteria are used by MUST to determine the overall risk for malnutrition: current weight status using BMI, unintentional weight loss, and acute disease effect.

5 secondary outcomes

Body Mass Index
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Body Fat
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Phase Angle
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Nutritional Risk Screening (NRS) Rates
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)
Subjective Global Assessment (SGA) Rates
Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GEP NET	399	399

Primary outcome: Prevalence of Malnutrition in GEP NET

Time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature). Count of participants. Unit: Participants

Measure	GEP NET n = 399
Malnutrition (GLIM criteria)	247
No malnutrition	152

Primary outcome: Risk of Malnutrition in GEP NET

Measure	GEP NET n = 399
Low risk	264
Intermediate risk	67
High risk	56
Missing	12

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Deaths and Adverse Events were not assessed. Safety was not within the scope of this observational study and was not assessed. The study is a single point visit. There is no prospective data collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GEP NET	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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. This study is not recruiting at the moment.

María Isabel del Olmo García, M.D. Ph.D. principal investigator

Hospital Universitario La Fe

María Argente Pla, M.D. Ph.D. principal investigator

Hospital Universitario La Fe

16 sites 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 Grupo Espanol de Tumores Neuroendocrinos at 16 sites in Spain.

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 5 inclusion and 5 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain. 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?

Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Prevalence of Malnutrition in GEP NET (time frame: Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986085.

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 28 Mar 2025.