MalnutritionMALNUTRITIONNCT06499623
Early Detection of Malnutrition in Oncology Patients and Elderly Patients
An observational study of Malnutrition, run by Institute of Health Information and Statistics of the Czech Republic at 9 sites in Czechia.
Trial summary
The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Blood test, Bioelectrical Impedance Analysis and Nutritional Risk Assessment Questionnaire
- How many people
- 1,264 participants
- Where
- 9 sitesCzechia
- Study dates
- 29 Aug 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with oncological diagnosis with age 18+ or patients with hospitalization at least 14 days and age 65+.
Who may be able to join
- Cohort Oncological patients:
- 18+
- an oncological diagnosis
- a survival prognosis of at least 3 months
- Cohort Patients older than 65 years:
- 65+
- hospitalization at least 14 days or longer
Who cannot join
- not agreeing to participate in the project
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Czechia9 sites
Brno University Hospital
Brno, 60200
Masaryk Memorial Cancer Institute
Brno, 60200
Hospital AGEL Nový Jičín a.s.
Nový Jičín
University Hospital Olomouc
Olomouc
University Hospital Pilsen
Pilsen
Bulovka Hospital
Prague
General University Hospital, Prague
Prague
Military University Hospital, Prague
Prague
University Hospital, Motol
Prague
About this study
Official title: Early Detection of Malnutrition in Oncology Patients and People Over 65 Years of Age
The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic.
The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.
Read the detailed description
The main goal of the project is the early detection of malnutrition in oncology patients and hospitalised patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.
Another goal of the project will be the creation of a unified diagnostic proposal process and methodological material for determining malnutrition. This process will then be designed as the standard of nursing practice for patients with an oncological diagnosis and for persons older than 65 years such that, so that an adequate nutritional intervention is started in time, which will lead to a higher tolerance of demanding treatment and thus to increase the quality of life.
The project will include testing the procedure on a sample of approx. 1,500 oncological and 500 geriatric patients.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000282.
- Conditions
- Malnutrition
- Being tested
- Blood test, Bioelectrical Impedance Analysis, Nutritional Risk Assessment Questionnaire
- Keywords
- malnutrition, oncology, gerontology
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Albumin, C-Reactive Protein, Cholesterol, Urea, Creatinine, Vitamin D
Bioelectrical Impedance AnalysisDiagnostic test
Total Impedance, Segmental Muscle Analysis, Segmental Fat Analysis, Absolute Muscle Mass Value, Muscle Mass Index, Total Body Fat Percentage, Total Body Water, Phase Angle Measurement
Nutritional Risk Assessment QuestionnaireOther
Fill in the Questionnaire of the Working Group on Nutritional Care in Oncology and get nutrition risk score. The objective data includes weight loss in 6 months, current BMI and food tolerance, and oncological diagnosis including ongoing anti-cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Oncological patients | The inclusion criteria for the cohort of oncological patients are age 18+, an oncological diagnosis and a survival prognosis of at least 3 months. Receives: Diagnostic Test: Blood test; Diagnostic Test: Bioelectrical Impedance Analysis; Other: Nutritional Risk Assessment Questionnaire | |
| Patients older than 65 years | The inclusion criteria for this cohort are age 65 and older and hospitalization at least 14 days or longer. Receives: Diagnostic Test: Blood test; Diagnostic Test: Bioelectrical Impedance Analysis; Other: Nutritional Risk Assessment Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people with malnutrition according to the PSNPO questionnaire
Measured: Until 31. 3. 2026
Secondary outcomes (1)
Proportion of people with initiated nutritional intervention
Measured: Until 31. 3. 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start29 Aug 2024
- Primary completion30 Nov 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- Brno University Hospital, Bulovka Hospital, Masaryk Memorial Cancer Institute, University Hospital, Motol, Hospital AGEL Nový Jičín a.s., Military University Hospital, Prague, General University Hospital, Prague, University Hospital Olomouc, University Hospital Pilsen
- Responsible party
- Sponsor
- Investigators
- Petra Beran Holeckova, MD, Study director, Charles University First Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499623
- Sponsor's protocol ID
- UZIS 2024/1
- Acronym
- MALNUTRITION
- Status last verified
- Nov 2026
- First submitted
- 8 Jul 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Malnutrition in Oncology Patients and People Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT06499623
- Acronym / sponsor ID
- MALNUTRITION / UZIS 2024/1
- Conditions
- Malnutrition
- Keywords
- malnutrition, oncology, gerontology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,264 participants (actual)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- Brno University Hospital, Bulovka Hospital, Masaryk Memorial Cancer Institute, University Hospital, Motol, Hospital AGEL Nový Jičín a.s., Military University Hospital, Prague, General University Hospital, Prague, University Hospital Olomouc, University Hospital Pilsen
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the Czech Republic.
The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.
Detailed description
The main goal of the project is the early detection of malnutrition in oncology patients and hospitalised patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.
Another goal of the project will be the creation of a unified diagnostic proposal process and methodological material for determining malnutrition. This process will then be designed as the standard of nursing practice for patients with an oncological diagnosis and for persons older than 65 years such that, so that an adequate nutritional intervention is started in time, which will lead to a higher tolerance of demanding treatment and thus to increase the quality of life.
The project will include testing the procedure on a sample of approx. 1,500 oncological and 500 geriatric patients.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0000282.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncological patients | – | Diagnostic Test: Blood test, Diagnostic Test: Bioelectrical Impedance Analysis, Other: Nutritional Risk Assessment QuestionnaireThe inclusion criteria for the cohort of oncological patients are age 18+, an oncological diagnosis and a survival prognosis of at least 3 months. |
| Patients older than 65 years | – | Diagnostic Test: Blood test, Diagnostic Test: Bioelectrical Impedance Analysis, Other: Nutritional Risk Assessment QuestionnaireThe inclusion criteria for this cohort are age 65 and older and hospitalization at least 14 days or longer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with oncological diagnosis with age 18+ or patients with hospitalization at least 14 days and age 65+.
Key inclusion criteria (7 listed)
- 18+
- an oncological diagnosis
- a survival prognosis of at least 3 months
- 65+
- hospitalization at least 14 days or longer
Key exclusion criteria (1 listed)
- not agreeing to participate in the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAlbumin, C-Reactive Protein, Cholesterol, Urea, Creatinine, Vitamin D | Diagnostic test | Oncological patients, Patients older than 65 years |
| Bioelectrical Impedance AnalysisTotal Impedance, Segmental Muscle Analysis, Segmental Fat Analysis, Absolute Muscle Mass Value, Muscle Mass Index, Total Body Fat Percentage, Total Body Water, Phase Angle Measurement | Diagnostic test | Oncological patients, Patients older than 65 years |
| Nutritional Risk Assessment QuestionnaireFill in the Questionnaire of the Working Group on Nutritional Care in Oncology and get nutrition risk score. The objective data includes weight loss in 6 months, current BMI and food tolerance, and oncological diagnosis including ongoing anti-cancer treatment. | Other | Oncological patients, Patients older than 65 years |
Primary outcome
Number of people with malnutrition according to the PSNPO questionnaire
Time frame: Until 31. 3. 2026
1 secondary outcome
Proportion of people with initiated nutritional intervention
Time frame: Until 31. 3. 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Petra Beran Holeckova, MD study director
Charles University First Faculty of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Institute of Health Information and Statistics of the Czech Republic at 9 sites in Czechia.
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 7 inclusion and 1 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of people with malnutrition according to the PSNPO questionnaire (time frame: Until 31. 3. 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.