CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-74
SponsorGulbenkian Institute for Molecular Medicine
About this trial
Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths globally, with increasing incidence rates. While predominantly affecting older adults, CRC cases among individuals under 50 (early-onset CRC, or EoCRC) are rising. This age group rarely undergoes routine screening, resulting in delayed diagnoses and more advanced disease at presentation. In the USA, EoCRC accounts for 10% of CRC cases and is the leading cause of cancer-related deaths in men under 50.
Despite the increase in EoCRC incidence, the causes remain unclear. Only 25% of cases have a CRC family history, suggesting environmental factors. Diets low in fibre and rich in fat and red meat, obesity, alcohol consumption, sedentary lifestyle, stress, and chronic inflammation of the GI tract are estimated to account for 70-90% of CRC risk. According to the World Cancer Research Fund, 47% of all CRC cases could be prevented through lifestyle changes, particularly in diet and physical activity.
These lifestyle factors are also strongly linked to changes in the gut microbiome, which differs markedly between CRC patients and healthy individuals. The microbiome may influence tumour development by producing metabolites that regulate immune responses or create anti-tumour environments. Thus, the gut microbiome is a promising target for early CRC detection and prevention.
This study aims to develop a non-invasive, microbiome-based diagnostic tool for CRC, identifying biomarkers to improve early detection, personalise treatment, and reduce healthcare costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be willing and able to provide written informed consent
Resident in Portugal
Age from 40 to 74 years
Have a recent diagnosis of CRC without initiating any treatment.
Disqualifiers
Age < 40 years or ≥ 75 years
Unable to provide informed consent
Refusal to provide stool samples
Previous or current treatment for CRC
Trial population
The recruitment for this study will be conducted in close collaboration with the oncology and general surgery departments from partner hospitals. Participants who meet all eligible criteria will be selected and provided with detailed information about the clinical study by study coordinators at each hospital. Those who agree to participate will be required to sign an informed consent form.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention: observational study
Other interventionNo intervention: observational study
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Colorectal Cancer (CRC)1 intervention
Trial outcomes
Primary outcomes
1
Microbiome biomarkers associated with CRC.
The faecal microbiome's composition and gene profiles will be analysed using shotgun metagenomic sequencing. Data will be integrated with lifestyle and dietary factors to identify biomarkers linked to CRC stages.
Time frame
Baseline and Follow-up up to 3 years2
Microbiome biomarkers associated with EoCRC.
Similar analysis as Outcome number 1, focused specifically on early-onset CRC cases.
Time frame
Baseline and Follow-up up to 3 years3
Correlation between microbiome biomarkers and overall survival and disease-free survival.
Biomarkers will be correlated with clinical follow-up data, including overall survival (survivors vs non-survivors) and disease-free progression (relapse vs no relapse).
Time frame
3 yearsSecondary outcomes
1
Effect of diet on CRC risk and gut microbiota composition
Dietary intake will be assessed via telephone interviews using two 24-hour dietary recalls. These follow protocols validated by the European Food Safety Authority (EFSA) and the Portuguese National Food and Physical Activity Survey (IAN-AF).
Time frame
Baseline2
Effect of the Mediterranean Diet (MD) on CRC risk and gut microbiota composition
Adherence to the MD will be assessed with the PREvención con DIeta MEDiterránea (PREDIMED) questionnaire, a validated 14-item tool. Scores (0-14) will categorise adherence as low (\<5), moderate (6-9), or high (\>10).
Time frame
Baseline3
Effect of physical activity on CRC risk and gut microbiota composition
Physical activity will be assessed using the Nordic Physical Activity Questionnaire-Short (NAPQ-short) form, which evaluates adherence to WHO physical activity recommendations.
Time frame
Baseline4
Effect of sleeping habits on CRC risk and gut microbiota composition
Sleeping habits will be assessed by the Pittsburgh Sleep Quality Index, a validated questionnaire that consists of 19 items which are distributed into seven "components": subjective sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbances; use of sleeping medication; day-time dysfunction. Each component is scored from 0 to 2, and the sum of the component scores yields a global PSQI score. A global PSQI score of ≥6 will indicate poor sleep quality.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gulbenkian Institute for Molecular Medicine
Lead sponsor
Fundacao Champalimaud
Collaborator
Centro Hospitalar Lisboa Norte
Collaborator
Source ClinicalTrials.gov