Cachexia; CancerCOMUNEXNCT03789136
The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism
An observational study of Cachexia; Cancer, run by Wageningen University at 1 site in Netherlands.
Trial summary
Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cachexia; Cancer
- What is being tested?
- Not applicable, observational study
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Feb 2017to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 40 colon cancer (CC) patients (♀ and ♂) undergoing primary tumor resection operation (30 patients) or liver metastases surgery (10 patients) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5) will be included in the study. Since the investigators do not know the number of patients in the colon cancer group willing to cooperate in the study, the investigators decided to take 5 patients of each control group (50% men and women). Note: during the study the investigators see more men than women joining the study so therefore the investigators raised the number of male controls to 10.
Who may be able to join
- CC patients:
- In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
- Diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10)
- Eligible for a primary tumor or liver metastases resection procedure
- Controls:
- Eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5)
Who cannot join
- CC patients:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Having had chemotherapy or an operational procedure of the abdomen in the past 6 months
- Suffering from malabsorption
- Controls:
- Having had treatment for previous or current tumors
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Gelderse Vallei Hospital
Ede, Gelderland, 6716 RP
Dik Snijdelaar, md, snijdelaarD@zgv.nl
About this study
Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance.
Objective: Main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls.
Read more
Study design: Observational study Study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5).
Main study parameters/endpoints: Primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary parameters will be body composition (determined in available CT scans and bio impedance analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators expect no additional risk for the subjects due to the proposed measurements. Biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. All other measurements are non-invasive, observational measurements with no risk of any harmful side effects.
- Conditions
- Cachexia; Cancer
- Being tested
- Not applicable, observational study
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable, observational studyOther
Not applicable, observational study
| Study group | Role | What they receive |
|---|---|---|
| Primary colon cancer | Not described Receives: Other: Not applicable, observational study | |
| Liver metastases | Not described Receives: Other: Not applicable, observational study | |
| Inguinal hernia (control) | Not described Receives: Other: Not applicable, observational study | |
| Abdominal hysterectomy (control) | Not described Receives: Other: Not applicable, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle gene expression
Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis
Measured: Biopsy during surgery
Secondary outcomes (7)
Body composition
Measured using single slice staining of CT scan made for diagnostic purposes.
Measured: Before surgery
Muscle function
Measured using hand-grip strength
Measured: Before surgery
Muscle protein metabolism
Measured in a muscle biopsy taken from the rectus abdominis
Measured: Biopsy during surgery
Adipose tissue gene expression
Adipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat
Measured: Biopsy during surgery
Cytokine parameters in the blood
Blood plasma cytokine levels measured using multiplex or similar technique
Measured: Blood taken prior to surgery
Micro-nutrient parameters in the blood
Micro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques
Measured: Blood taken prior to surgery
Cholesterol levels in the blood
Cholesterol levels in the blood measured by GCMS
Measured: Blood taken prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start24 Feb 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Klaske van Norren, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789136
- Sponsor's protocol ID
- NL58188.081.16
- Acronym
- COMUNEX
- Status last verified
- Jun 2021
- First submitted
- 7 Dec 2018
- Last updated
- 29 Jun 2021
- Results posted
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism
- ClinicalTrials.gov ID
- NCT03789136
- Acronym / sponsor ID
- COMUNEX / NL58188.081.16
- Conditions
- Cachexia; Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Top Institute Food and Nutrition
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Dec 2018 (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.
Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance.
Objective: Main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls.
Study design: Observational study Study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5).
Main study parameters/endpoints: Primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary parameters will be body composition (determined in available CT scans and bio impedance analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators expect no additional risk for the subjects due to the proposed measurements. Biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. All other measurements are non-invasive, observational measurements with no risk of any harmful side effects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary colon cancer | – | Other: Not applicable, observational study |
| Liver metastases | – | Other: Not applicable, observational study |
| Inguinal hernia (control) | – | Other: Not applicable, observational study |
| Abdominal hysterectomy (control) | – | Other: Not applicable, observational study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 40 colon cancer (CC) patients (♀ and ♂) undergoing primary tumor resection operation (30 patients) or liver metastases surgery (10 patients) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5) will be included in the study. Since the investigators do not know the number of patients in the colon cancer group willing to cooperate in the study, the investigators decided to take 5 patients of each control group (50% men and women). Note: during the study the investigators see more men than women joining the study so therefore the investigators raised the number of male controls to 10.
Key inclusion criteria (6 listed)
- CC patients:
- In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
- Diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10)
- Eligible for a primary tumor or liver metastases resection procedure
- Eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5)
Key exclusion criteria (6 listed)
- CC patients:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Having had chemotherapy or an operational procedure of the abdomen in the past 6 months
- Suffering from malabsorption
- Having had treatment for previous or current tumors
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 |
|---|---|---|
| Not applicable, observational studyNot applicable, observational study | Other | Abdominal hysterectomy (control), Inguinal hernia (control), Liver metastases, Primary colon cancer |
Primary outcome
Muscle gene expression
Time frame: Biopsy during surgery
Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis
7 secondary outcomes
Body composition
Time frame: Before surgery
Muscle function
Time frame: Before surgery
Muscle protein metabolism
Time frame: Biopsy during surgery
Adipose tissue gene expression
Time frame: Biopsy during surgery
Cytokine parameters in the blood
Time frame: Blood taken prior to surgery
Micro-nutrient parameters in the blood
Time frame: Blood taken prior to surgery
Cholesterol levels in the blood
Time frame: Blood taken prior to surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- 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.
Klaske van Norren, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia; Cancer, run by Wageningen University at 1 site in Netherlands.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaske van Norren, PhD (+31317485790, klaske.vannorrren@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle gene expression (time frame: Biopsy during surgery). 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 29 Jun 2021.