NCT06499623

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

July 8, 2024

Last Update Submit

October 1, 2024

Conditions

Malnutrition

Keywords

malnutritiononcologygerontology

Outcome Measures

Primary Outcomes (1)

  • Number of people with malnutrition according to the PSNPO questionnaire

    Until 31. 3. 2026

Secondary Outcomes (1)

  • Proportion of people with initiated nutritional intervention

    Until 31. 3. 2026

Study Arms (2)

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.

Diagnostic Test: Blood testDiagnostic Test: Bioelectrical Impedance AnalysisOther: 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.

Diagnostic Test: Blood testDiagnostic Test: Bioelectrical Impedance AnalysisOther: Nutritional Risk Assessment Questionnaire

Interventions

Blood testDIAGNOSTIC_TEST

Albumin, C-Reactive Protein, Cholesterol, Urea, Creatinine, Vitamin D

Oncological patientsPatients older than 65 years
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

Oncological patientsPatients older than 65 years
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.

Oncological patientsPatients older than 65 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with oncological diagnosis with age 18+ or patients with hospitalization at least 14 days and age 65+.

You may qualify if:

  • Cohort Oncological patients:
  • an oncological diagnosis
  • a survival prognosis of at least 3 months
  • Cohort Patients older than 65 years:
  • hospitalization at least 14 days or longer

You may not qualify if:

  • not agreeing to participate in the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Brno University Hospital

Brno, 60200, Czechia

ENROLLING BY INVITATION

Masaryk Memorial Cancer Institute

Brno, 60200, Czechia

RECRUITING

Hospital AGEL Nový Jičín a.s.

Nový Jičín, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Czechia

ENROLLING BY INVITATION

University Hospital Pilsen

Pilsen, Czechia

ENROLLING BY INVITATION

Bulovka Hospital

Prague, Czechia

RECRUITING

General University Hospital, Prague

Prague, Czechia

ENROLLING BY INVITATION

Military University Hospital, Prague

Prague, Czechia

RECRUITING

University Hospital, Motol

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

MalnutritionNeoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Petra Beran Holeckova, MD

    Charles University First Faculty of Medicine

    STUDY DIRECTOR

Central Study Contacts

Nikola Stourac

CONTACT

+420 739 012 354nikola.stourac@uzis.cz

Lucie Mandelova, PhD

CONTACT

+420 770 190 828lucie.mandelova@uzis.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 12, 2024

Study Start

August 29, 2024

Primary Completion

November 30, 2025

Study Completion

March 31, 2026

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(9)