Actively Recruiting

Age: 40Years - 74Years
All Genders
NCT06734156

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

Led by Gulbenkian Institute for Molecular Medicine · Updated on 2026-05-12

400

Participants Needed

2

Research Sites

195 weeks

Total Duration

On this page

Sponsors

G

Gulbenkian Institute for Molecular Medicine

Lead Sponsor

F

Fundacao Champalimaud

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be willing and able to provide written informed consent
  • Resident in Portugal
  • Age from 40 to 74 years
  • Have a recent diagnosis of colorectal cancer without starting any treatment
Not Eligible

You will not qualify if you...

  • Age younger than 40 years or 75 years and older
  • Unable to provide informed consent
  • Refusal to provide stool samples
  • Previous or current treatment for colorectal cancer
  • First-degree family history of colorectal cancer
  • Previous diagnosis of inflammatory bowel disease, irritable bowel syndrome, or recurrent Clostridioides difficile infection
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Champalimaud Foundation

Lisbon, Lisbon District, Portugal, 1400-038

Actively Recruiting

2

Gulbenkian Institute for Molecular Medicine

Lisbon, Lisbon District, Portugal, 1649-028

Actively Recruiting

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Research Team

A

Ana S Almeida, PhD

CONTACT

M

Madalena Reis

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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