An observational study in Colorectal Cancer and Cancer Cachexia, sponsored by Hasselt University. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Hasselt University · Observational
Until now, cancer is still associated with high morbidity and mortality, and is therefore a big issue for the public health. Colorectal cancer is the second leading cause of cancer death in developed countries. In advanced colorectal cancer, 60% of these patients develop cachexia. The presence of cachexia plays an important role in the high mortality rate of cancer. Cachexia is characterized by involuntary weight loss with loss of skeletal muscle with or without loss of fat mass.
The aim of this study is to determine the feasibility of taking muscle biopsies of cachectic colorectal cancer patients. Skeletal muscle characteristics will be compared between biopsies of the m. erector spinae and the m. vastus lateralis from cachectic colorectal cancer patients, non-cachectic colorectal cancer patients and healthy controls.
10 cachectic, 25 non-cachectic, and 25 healthy controls will be recruited for this study. It is an observational study, so measurements will be taken at one time point. Interventions/measurements:
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 60 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hasselt University is the lead sponsor of 204 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
12 cachectic colorectal cancer patients, 25 non-cachectic colorectal cancer patients, and 25 healthy controls will be recruited in the study. Colorectal cancer patients will be recruited by the surgeans from the Jessa Hospital (Hasselt, Belgium), and the healthy controls will be recruited by the local researcher from Hasselt University.
Cachectic colorectal cancer patients.
Inclusion criteria:
Exclusion Criteria:
Non-Cachectic cancer patients.
Inclusion criteria:
Exclusion criteria:
Healthy controls.
Inclusion criteria:
- minimum age of 18 years old
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Minimal invasive fine needle muscle biopsies
Procedure: Minimal invasive fine needle muscle biopsies
Procedure: Minimal invasive fine needle muscle biopsies
Fine needle muscle biopsies will be taken from the m. erector spinae and the m. vastus lateralis. Participants are placed in a standardized prone position on the examination table for measurements of the m. erector spinae and in a supine position for measurements of the m. vastus lateralis.
Skeletal muscle fiber typing
Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)
Time frame: at enrollment
skeletal muscle nuclei
Immunofluorescence staining with DAPI
Time frame: at enrollment
Inflammatory parameters
ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)
Time frame: at enrollment
Mitochondrial morphology
mitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)
Time frame: at enrollment
3D freehand ultrasound
measuring the volume of the m. rectus femoris
Time frame: at enrollment
CT-scans
level lumbar 3 To calculate the cross-sectional area of the m. erector spinae.
Time frame: at enrollment
Activity pattern
PASIPD questionnaire
Time frame: at enrollment
VAS score
to descripe the pain at the moment of the biopsy procedure. Score range is 0 to 10. With 0 no pain until 10 the worst pain.
Time frame: at enrollment
Handgrip strength
Using the JAMAR to measure the handgripstrength
Time frame: at enrollment
Short Physical Performance Battery (SPPB) test
Including a balance test, sit-to-stand test and four meter walking test
Time frame: at enrollment
Quality of Life questionnaire
SF-36 questionnaire 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: at enrollment
skeletal muscle capillarization
Immunofluorescence staining for capillaries in the skeletel muscle biopsies.
Time frame: at enrollment
Ran from Jan 2022 to primary completion in Mar 2025, 37 months.
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