Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
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| First Received Date ICMJE | February 10, 2012 | ||||||||
| Last Updated Date | March 29, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Nutritional Assessment [ Time Frame: 4 times in 6 months ] [ Designated as safety issue: No ] Patient-Generated Subjective Global Assessment Instrument is a measure for the nutritional status of the participants. The final score of this instruments devides participants into three categories: well-nourished, moderately nourished or suspected malnourished. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01533909 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients | ||||||||
| Official Title ICMJE | Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients | ||||||||
| Brief Summary | The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care. |
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| Detailed Description | In this cross-sectional study, the participants will complete 4 times a set of questionnaires and measurements. The data that will be collected is: age; sex; height; weight; type of tumour; classification of malignant tumours (TNM); progression of tumour and used therapy; blood sample to analyse albumin, creatine, hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm circumference. Based on all these data points a easy to use tool/score for a hospital setting will be created. During the first assessment the measurements will be done in the morning and the evening to test the reproducibility. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: The blood sample that will be collected is part of the routine hospital assessment. The biomarkers that will be measured are albumine, creatine, CRP, hemoglobin and Lactate dehydrogenase (LDH). |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town). (Limit: 1000 characters) |
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| Condition ICMJE | Cachexia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Cancer patients
As this is not an intervention study there is only one cohort. Patients that will be included and excluded are described in the eligibility section. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 95 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01533909 | ||||||||
| Other Study ID Numbers ICMJE | S54035 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Universitaire Ziekenhuizen Leuven | ||||||||
| Study Sponsor ICMJE | Universitaire Ziekenhuizen Leuven | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Universitaire Ziekenhuizen Leuven | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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