Colorectal CancerCTLm-CCPNCT06780423
Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
An observational study of Colorectal Cancer and Cancer Cachexia, run by Hasselt University at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Cancer Cachexia
- What is being tested?
- Minimal invasive fine needle muscle biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesBelgium
- Study dates
- 23 Jan 2022to 10 Sep 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- minimum age of 18 years old
- unwanted weight loss > 5% in the last 6 months OR > 2% unwanted weight loss in combination with a BMI < 20kg/m2 OR >2% unwanted weight loss in combination with sarcopenia
- Cachexia staging score (CSS): 5-12
- minimum age of 18 years old
- No unwanted weight loss > 5% in the last 6 months OR > 2% unwanted weight loss in combination with a BMI < 20kg/m2 OR >2% unwanted weight loss in combination with sarcopenia
- Cachexia staging score (CSS): 0-2
- minimum age of 18 years old
Who cannot join
- Mental of psychological condition
- Insufficient knowledge of the Dutch language
- Muscle diseases affecting the spine and lower limbs
- Bedridden
- Non-Cachectic cancer patients.
- Mental of psychological condition
Show all 14Show fewer
- Insufficient knowledge of the Dutch language
- Muscle diseases affecting the spine and lower limbs
- Bedridden
- Healthy controls.
- Mental of psychological condition
- Insufficient knowledge of the Dutch language
- Muscle diseases affecting the spine and lower limbs
- Bedridden
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenneth Verboven, Professor contact
Belgium2 sites, 2 recruiting
- Recruiting
Hasselt University - REVAL research institution
Diepenbeek, Limburg, 3520
Kenneth Verboven, Professor, +3211269315, kenneth.verboven@uhasselt.be
Britt van de Haterd, PhD student, 0032479871509, britt.vandehaterd@uhasselt.be
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Bert Houben, Doctor, +3211 33 75 19, bert.houben@jessazh.be
About this study
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.
Read more
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:
- muscle biopsies
- blood samples
- 3D freehand ultrasound
- Short physical performance battery test
- handgrip strength
- questionnaires (activity pattern, quality of life)
- Conditions
- Colorectal Cancer, Cancer Cachexia
- Being tested
- Minimal invasive fine needle muscle biopsies
- Keywords
- colorectal cancer, cachexia, skeletal muscle, skeletal muscle fibers, capillarization
- Medical subject headings
- Colorectal Neoplasms, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive fine needle muscle biopsiesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cachectic colorectal cancer patients | Not described Receives: Procedure: Minimal invasive fine needle muscle biopsies | |
| Non-cachectic colorectal cancer patients | Not described Receives: Procedure: Minimal invasive fine needle muscle biopsies | |
| Healthy controls | Not described Receives: Procedure: Minimal invasive fine needle muscle biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle fiber typing
Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)
Measured: at enrollment
skeletal muscle nuclei
Immunofluorescence staining with DAPI
Measured: at enrollment
Inflammatory parameters
ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)
Measured: at enrollment
Mitochondrial morphology
mitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)
Measured: at enrollment
Secondary outcomes (8)
3D freehand ultrasound
measuring the volume of the m. rectus femoris
Measured: at enrollment
CT-scans
level lumbar 3 To calculate the cross-sectional area of the m. erector spinae.
Measured: at enrollment
Activity pattern
PASIPD questionnaire
Measured: 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.
Measured: at enrollment
Handgrip strength
Using the JAMAR to measure the handgripstrength
Measured: at enrollment
Short Physical Performance Battery (SPPB) test
Including a balance test, sit-to-stand test and four meter walking test
Measured: 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.
Measured: at enrollment
skeletal muscle capillarization
Immunofluorescence staining for capillaries in the skeletel muscle biopsies.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start23 Jan 2022
- Primary completion15 Mar 2025
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Kenneth Verboven, Hasselt University
- Investigators
- Kenneth Verboven, Professor, Principal investigator, Hasselt University - REVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780423
- Sponsor's protocol ID
- 2021/148 - CTLm-CCP
- Acronym
- CTLm-CCP
- Status last verified
- Sep 2025
- First submitted
- 13 Jan 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06780423
- Acronym / sponsor ID
- CTLm-CCP / 2021/148 - CTLm-CCP
- Conditions
- Colorectal Cancer, Cancer Cachexia
- Keywords
- colorectal cancer, cachexia, skeletal muscle, skeletal muscle fibers, capillarization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 17 Jan 2025 (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.
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:
- muscle biopsies
- blood samples
- 3D freehand ultrasound
- Short physical performance battery test
- handgrip strength
- questionnaires (activity pattern, quality of life)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cachectic colorectal cancer patients | – | Procedure: Minimal invasive fine needle muscle biopsies |
| Non-cachectic colorectal cancer patients | – | Procedure: Minimal invasive fine needle muscle biopsies |
| Healthy controls | – | Procedure: Minimal invasive fine needle muscle biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- minimum age of 18 years old
- unwanted weight loss > 5% in the last 6 months OR > 2% unwanted weight loss in combination with a BMI < 20kg/m2 OR >2% unwanted weight loss in combination with sarcopenia
- Cachexia staging score (CSS): 5-12
- minimum age of 18 years old
- No unwanted weight loss > 5% in the last 6 months OR > 2% unwanted weight loss in combination with a BMI < 20kg/m2 OR >2% unwanted weight loss in combination with sarcopenia
Key exclusion criteria (14 listed)
- Mental of psychological condition
- Insufficient knowledge of the Dutch language
- Muscle diseases affecting the spine and lower limbs
- Bedridden
- Non-Cachectic cancer patients.
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 |
|---|---|---|
| Minimal invasive fine needle muscle biopsiesFine 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. | Procedure or surgery | Cachectic colorectal cancer patients, Healthy controls, Non-cachectic colorectal cancer patients |
Primary outcome
Skeletal muscle fiber typing
Time frame: at enrollment
Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)
skeletal muscle nuclei
Time frame: at enrollment
Immunofluorescence staining with DAPI
Inflammatory parameters
Time frame: at enrollment
ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)
Mitochondrial morphology
Time frame: at enrollment
mitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)
8 secondary outcomes
3D freehand ultrasound
Time frame: at enrollment
CT-scans
Time frame: at enrollment
Activity pattern
Time frame: at enrollment
VAS score
Time frame: at enrollment
Handgrip strength
Time frame: at enrollment
Short Physical Performance Battery (SPPB) test
Time frame: at enrollment
Quality of Life questionnaire
Time frame: at enrollment
skeletal muscle capillarization
Time frame: at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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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.
Kenneth Verboven, Professor contact
Kenneth Verboven, Professor principal investigator
Hasselt University - REVAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Cancer Cachexia, run by Hasselt University at 2 sites in Belgium.
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 14 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Britt van de Haterd, PhD student (0032479871509, britt.vandehaterd@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle fiber typing (time frame: at enrollment). The study lists 4 primary outcomes in all. 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 9 Sep 2025.