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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEP NET | GEP NET patients in Spain |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
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:
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Adult patients with gastroenteropancreatic neuroendocrine tumors diagnosed histologically that are on active treatment for the disease in Spain
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa Isabel del Olmo GarcÃa, M.D. Ph.D. | Hospital Universitario La Fe | Principal Investigator |
| MarÃa Argente Pla, M.D. Ph.D. | Hospital Universitario La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain | ||
| Hospital Universitario Vall d´Hebron |
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| ID | Title | Description |
|---|---|---|
| FG000 | GEP NET | GEP NET patients in Spain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full dataset
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| ID | Title | Description |
|---|---|---|
| BG000 | GEP NET | GEP NET patients in Spain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GEP NET | GEP NET patients in Spain | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A responsible Person Designated by the Sponsor | Grupo Español de Tumores Neuroendocrinos y Endocrinos | 0034934344412 | investigacion@mfar.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2021 | Mar 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Body fat mass calculated by bioimpedance |
| 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. | 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). | 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) | Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature) |
| Barcelona |
| 08035 |
| Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario de Cabueñes | Gijón | 33394 | Spain |
| Hospital Universitario Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario la Paz | Madrid | 28046 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital ClÃnico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Universitari i Poliècnic la Fe | Valencia | 40026 | Spain |
| Institut Valencià d'Oncologia (IVO) | Valencia | 46009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group performance status (ECOG-PS) | The ECOG PS score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The score ranges from 0 (Fully active, able to carry on all pre-disease performance without restriction) to 5 (dead) | Count of Participants | Participants |
|
| Tumor grade; World Health Organization (WHO) | The pathologist gives the NET a grade from 1 to 3. A lower number means the tumour is a lower grade. The factors used to determine the grade for NETs include: how often the cells of the tumour are dividing (measured as mitotic count and Ki-67 labelling index). Higher grade indicates a less differentiated tumor with more aggressive behaviour | Count of Participants | Participants |
|
| Tumor Differentiation | Well-differentiated neuroendocrine tumors (NETs): The cells resemble and behave like normal cells and tend to grow slowly. Most Grade 1 and Grade 2 NETs are this type. Poorly differentiated neuroendocrine carcinomas (NEC): These cells look abnormal and don't resemble or behave like normal cells. They tend to grow fast. | Count of Participants | Participants |
|
| Functionality | Some tumours (functioning tumours) may cause abnormally large amounts of hormones to be released into the bloodstream. This can cause symptoms such as diarrhoea, flushing, cramps, wheezing, low blood sugar (hypoglycaemia), changes in blood pressure and heart problems | Count of Participants | Participants |
|
| Primary tumor location | Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) are epithelial neoplasms with neuroendocrine differentiation that occur inside the gastrointestinal (GI) tract and the pancreas. Some tumors may be diagnosed by the presence of metastasis or appearance of symptoms in functioning tumors, while primary tumor remains undetermined, unknown origin. Here we report the primary tumor locations | Count of Participants | Participants |
|
| Metastasis at inclusion | The metastatic process involves tumor cell invasion of distant organs to the primary tumor site. Presence of metastasis may correlate with worse prognosis in most cases. Here we report the number of metastatic locations | Count of Participants | Participants |
|
| Most common sites of metastasis | Here we report the number of patients who hace metastasis in the most common organs / locations | Count of Participants | Participants |
|
| Previous lines of treatment | Here we report the number of previous systemic treatments received by the patients before the inclusion in the NUTRIGETNE study. | Count of Participants | Participants |
|
| Type of previous lines | Here we report the type of previous systemic treatments received by the patients before their inclusion in the NUTRIGETNE study. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 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 | 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 | The endpoint is reported in overall population and in subgroups. according to their sex and malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status. | Posted | Count of Participants | Participants | 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 | Body Fat | Body fat mass calculated by bioimpedance | The endpoint is reported in overall population and in subgroups. according to their sex and malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status. | Posted | Median | Full Range | Kg | 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 | 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. | The endpoint is reported in overall population and in subgroups. according to their sex and malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status. | Posted | Median | Full Range | degrees | 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 | 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). | The endpoint is reported in overall population and in subgroups. according to the malnutrition status. The analyzed patient number in each subgroup might be inferior to the full sample size as some patients may have missing BMI , or unknown GLIM malnutrition status. | Posted | Median | 95% Confidence Interval | Score | 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 | 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) | The endpoint is reported in overall population and in subgroups. according to the malnutrition status | Posted | Count of Participants | Participants | Throughout the study period. Nutritional status will be reported at a single timepoint for each patient (between 1-10 days after informed consent signature) |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009380 | Neoplasms, Nerve Tissue |
| Missing |
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| Overweight (BMI 25 - 30) |
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| Obese (BMI >= 30) |
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| Female |
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| Malnutrition (GLIM) |
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| No malnutrition (GLIM) |
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| Overall |
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| Malnutrition (GLIM) |
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| No Malnutrition (GLIM) |
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| Overall |
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| Malnutrition (GLIM) |
|
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| No malnutrition (GLIM) |
|
|
| Overall |
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|
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| Overall |
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| Severe malnutrition |
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| Missing data |
|
| No malnutrition (GLIM) |
|
|
| Overall |
|
|