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Trial record 1 of 1 for:    GETNE-S2109
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Nutrition in Gastroenteropancreatic Neuroendocrine Tumor (NUTRIGETNE)

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ClinicalTrials.gov Identifier: NCT04986085
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Tumores Neuroendocrinos

Brief Summary:

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.


Condition or disease
Gastroenteropancreatic Neuroendocrine Tumor

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Nutritional Status of Patients With Gastroenteropancreatic Neuroendocrine Tumors in Spain: NUTRIGETNE
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023


Group/Cohort
GEP NET
GEP NET patients in Spain



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 mass index (BMI) is defined as a a measure of body fat based on height and weight that applies to adult men and women

  2. 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) ]
    Body fat mass calculated by bioimpedance

  3. Body muscle mass [ 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 muscle mass calculated by bioimpedance

  4. 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) ]
    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).

  5. 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) ]
    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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patients with gastroenteropancreatic neuroendocrine tumors diagnosed histologically that are on active treatment for the disease in Spain
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04986085


Contacts
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Contact: A responsible person designated by the sponsor +34 93 434 44 12 investigacion@mfar.net

Locations
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Spain
Hospital Universitario Virgen de la Arrixaca Recruiting
El Palmar, Murcia, Spain, 30120
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Dr. Josep Trueta Recruiting
Gerona, Spain, 17007
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario de Cabueñes Recruiting
Gijón, Spain, 33394
Contact: A responsible person designated by the Sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario la Princesa Recruiting
Madrid, Spain, 28006
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario la Paz Recruiting
Madrid, Spain, 28046
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Spain, 39008
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Clínico Universitario de Santiago Recruiting
Santiago De Compostela, Spain, 15706
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitari i Poliècnic la Fe Recruiting
Valencia, Spain, 40026
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D. Ph.D.         
Institut Valencià d'Oncologia (IVO) Recruiting
Valencia, Spain, 46009
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: A responsible person designated by the sponsor       investigacion@mfar.net   
Principal Investigator: Principal investigator selected by the sponsor, M.D.         
Sponsors and Collaborators
Grupo Espanol de Tumores Neuroendocrinos
Investigators
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Principal Investigator: María Isabel del Olmo García, M.D. Ph.D. Hospital Universitario La Fe
Principal Investigator: María Argente Pla, M.D. Ph.D. Hospital Universitario La Fe
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Responsible Party: Grupo Espanol de Tumores Neuroendocrinos
ClinicalTrials.gov Identifier: NCT04986085    
Other Study ID Numbers: GETNE-S2109
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Grupo Espanol de Tumores Neuroendocrinos:
GEP NET
Neuroendocrine tumor
Nutritional status
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases