An observational study in Oncologic Diseases and Lung Cancer (NSCLC), sponsored by Casa di Cura Dott. Pederzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Casa di Cura Dott. Pederzoli · Observational
monitoring of the patient's nutritional status from diagnosis ensuring a dietetic-nutritional intervention throughout the treatment process
During the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology.
The final score (Total Score) is the sum of three parameters:
Based on the final score:
This nutritional dietary assessment is composed of:
Use of GLIM criteria for the diagnosis of malnutrition
The patient will then be assessed according to the GLIM (Global Leadership Initiative on Malnutrition) criteria, which are the international standard for the diagnosis and classification of malnutrition in adults. They are based on a two-stage process:
Initial screening: Identifies the risk of malnutrition using validated tools (NRS2002 test) Diagnosis: Requires the presence of at least one phenotypic criterion and one etiological criterion.
The Three Phenotypic Criteria serve to define the severity of malnutrition and are:
The Two Etiological Criteria serve to guide the therapeutic path and are:
This nutritional dietary assessment will be performed, in addition to the diagnosis (Time 0,) also at the following times:
Between one evaluation and the next, patients with screening ≥ 3 taken into care, as per clinical practice, from a dietary-nutritional point of view, will receive a personalized intervention on a regular basis (approximately every 30-50 days) that can make use of counseling and/or diet therapy and/or nutritional support (use of Oral Nutritional Supplement, enteral nutrition, parenteral nutrition). The study therefore also aims to monitor the frequency and type of nutritional intervention performed (nutritional counseling and/or diet therapy and/or nutritional support) and their correlation with other variables collected as per clinical practice.
Following the enlistment phase (2 years), subjects will be observed for a total duration of 1 year at the end of which a second year is foreseen for the analysis and drafting of the results. Patients will be evaluated through a follow-up visit as per clinical practice, and those who have completed follow-up at the hospital will be contacted by telephone for a telematic data update.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Casa di Cura Dott. Pederzoli is the lead sponsor of 15 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of advanced/metastatic non-small cell and small cell lung cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology. Based on the final score: * patients with a score \< 3 will receive simple nutritional advice from the oncologist on the correct management of their diet during treatment. * patients with score ≥ 3 will be enrolled, after signing the informed consent, and subjected to a dietary - nutritional assessment as per clinical practice. This nutritional dietary assessment is composed of: 1. Use of GLIM criteria for the diagnosis of malnutrition 2. Nutrition data collections 3. Completion of questionnaires for data collection on health-related quality of life and data on oncological fatigue
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of weight (kg)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of height (cm)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of BMI (kg/m^2)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of fatigue (Units on a Scale)
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of adverse events
Time frame: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of strength (Hand Grip)
Time frame: through study completion, an average of 1 year
Plan to share: No
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Casa di Cura Dott. Pederzoli