CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer

NCT06734156 | Not Yet Recruiting

• 2 other identifiers: CAML Ref nº 265/24101060102
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer (CRC); Microbiome; Early Onset Colorectal Cancer

Keywords

Colorectal Cancer; Gut Microbiota; Microbiome; Early-onset Colorectal Cancer; Biomarkers; Diet; Risk factors; Metagenomics

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Follow-up up to 3 years

• Microbiome biomarkers associated with EoCRC.

  Similar analysis as Outcome number 1, focused specifically on early-onset CRC cases.

  Baseline and Follow-up up to 3 years

• 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).

  3 years

Secondary Outcomes (7)

• Effect of diet on CRC risk and gut microbiota composition

  Baseline

• Effect of the Mediterranean Diet (MD) on CRC risk and gut microbiota composition

  Baseline

• Effect of physical activity on CRC risk and gut microbiota composition

  Baseline

• Effect of sleeping habits on CRC risk and gut microbiota composition

  Baseline

• Effect of stress levels on CRC risk and gut microbiota composition

  Baseline

Study Arms (1)

Colorectal Cancer (CRC)

Participants with a confirmed CRC diagnosis, stratified by age: 40-49, 50-59, 60-64, 65-69, and 70-74 years.

Other: No intervention: observational study

Interventions

No intervention: observational study OTHER

No intervention: observational study

Colorectal Cancer (CRC)

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 40 years or ≥ 75 years
• Unable to provide informed consent
• Refusal to provide stool samples
• Previous or current treatment for CRC
• First-degree family history of CRC
• Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile
• Pregnancy

Sponsors & Collaborators

• Gulbenkian Institute for Molecular Medicine: lead
• Fundacao Champalimaud: collaborator
• Centro Hospitalar Lisboa Norte: collaborator

Study Sites (1)

Gulbenkian Institute for Molecular Medicine

Lisbon, 1649-028, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples with DNA: Participants will collect stool samples at home using a self-collection kit provided at baseline. These samples will be transported to the laboratory within 48 hours, subdivided into aliquots, and stored at -80°C for future analysis. Additional stool samples will be collected post-treatment and at the three-year follow-up. Blood Samples: Blood samples will be collected in K2EDTA tubes, by healthcare professionals, and processed for plasma separation at the partner hospital. These samples will be transported to the GIMM Biobank and stored at -80°C for future analysis. Tumour Samples: For participants undergoing treatment with surgery, tumour samples will be collected during surgery, preserved, and processed for transcriptomic analysis.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ana S Almeida, PhD

  Gulbenkian Institute for Molecular Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana S Almeida, PhD

CONTACT

+351 217999411; ana.almeida@gimm.pt

Madalena Reis

CONTACT

+351 217999411; madalena.reis@gimm.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): December 2, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

PT (1)