The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism
NCT ID: NCT03789136
Last Updated: 2021-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
55 participants
OBSERVATIONAL
2017-02-24
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study
NCT04136249
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
NCT02573974
Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program
NCT05099211
Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment
NCT05648955
Early Nutritional Intervention in Patients With Cancer
NCT06141785
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Primary colon cancer
Not applicable, observational study
Not applicable, observational study
Liver metastases
Not applicable, observational study
Not applicable, observational study
Inguinal hernia (control)
Not applicable, observational study
Not applicable, observational study
Abdominal hysterectomy (control)
Not applicable, observational study
Not applicable, observational study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Not applicable, observational study
Not applicable, observational study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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)
Exclusion Criteria
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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gelderse Vallei Hospital
OTHER
Top Institute Food and Nutrition
OTHER
Wageningen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Klaske van Norren, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen University and Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL58188.081.16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.