Nutrition in Gastroenteropancreatic Neuroendocrine Tumor

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04986085
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Grupo Espanol de Tumores Neuroendocrinos
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

María Isabel del Olmo García, M.D. Ph.D.María Argente Pla, M.D. Ph.D.
Principal Investigator Affiliation Hospital Universitario La FeHospital Universitario La Fe
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gastroenteropancreatic Neuroendocrine Tumor
Additional Details

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.

Arms & Interventions

Arms

: GEP NET

GEP NET patients in Spain

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

El Palmar, Murcia, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario Vall d´Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Vall d´Hebron

Barcelona, , 08035

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario Reina Sofia, Córdoba, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Córdoba, , 14004

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario Dr. Josep Trueta, Gerona, Spain

Status

Recruiting

Address

Hospital Universitario Dr. Josep Trueta

Gerona, , 17007

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario de Cabueñes, Gijón, Spain

Status

Recruiting

Address

Hospital Universitario de Cabueñes

Gijón, , 33394

Site Contact

A responsible person designated by the Sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario la Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario la Princesa

Madrid, , 28006

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario Ramón y Cajal, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid, , 28034

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Clínico San Carlos

Madrid, , 28040

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario la Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario la Paz

Madrid, , 28046

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Oviedo, Spain

Status

Recruiting

Address

Hospital Universitario Central de Asturias

Oviedo, , 33011

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Santander, Spain

Status

Recruiting

Address

Hospital Universitario Marques de Valdecilla

Santander, , 39008

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Santiago De Compostela, Spain

Status

Recruiting

Address

Hospital Clínico Universitario de Santiago

Santiago De Compostela, , 15706

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitari i Poliècnic la Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Poliècnic la Fe

Valencia, , 40026

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Institut Valencià d'Oncologia (IVO), Valencia, Spain

Status

Recruiting

Address

Institut Valencià d'Oncologia (IVO)

Valencia, , 46009

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

Hospital Universitario Miguel Servet, Zaragoza, Spain

Status

Recruiting

Address

Hospital Universitario Miguel Servet

Zaragoza, , 50009

Site Contact

A responsible person designated by the sponsor

[email protected]

+34 93 434 44 12

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