Improving Colorectal Cancer Early Screening in Portugal: Identification and Validation of Biomarkers of Gut Microbiome in Stool

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Colorectal cancer (CRC) is a major public health problem, responsible for 2 million new cases and almost 1 million deaths annually worldwide. In Portugal, as of 2022, CRC is the most common cancer, with 10,575 new cases reported, and the second leading cause of cancer-related mortality, accounting for 4,809 deaths (approximately 14% of all cancer-related deaths). In recent years, there has been an alarming increase in the incidence and mortality of CRC in people \<50 years of age. Early detection is crucial, as survival rates decline sharply from 90% when detected early to just 10% in advanced stages. Non-invasive diagnostic tests, such as the Faecal Immunochemical Test (FIT), have a low sensitivity for early-stage lesions and a high rate of false positives. Therefore, there is an urgent need to improve non-invasive diagnostic methods for the early detection of CRC, as effective screening can prevent it by detecting and removing premalignant lesions. Recent studies suggest that an altered gut microbiota may confer susceptibility to certain types of cancer. Interestingly, the gut microbiota of patients with adenomas or CRC differs from that of healthy individuals. This study aims to identify gut microbiome biomarkers in faecal samples associated with CRC and/or high-risk adenomas to improve early detection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 74
Healthy Volunteers: t
View:

• Ability to provide written informed consent and comply with study procedures

• Reside in the Lisbon Metropolitan Area,, Portugal

• Age from 40 to 74 years

Locations
Other Locations
Portugal
Gulbenkian Institute for Molecular Medicine
RECRUITING
Lisbon
Contact Information
Primary
Ana S Almeida, PhD
ana.almeida@gimm.pt
+351 217999411
Backup
Madalena Reis
madalena.reis@gimm.pt
+351 217999411
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2029-11-28
Participants
Target number of participants: 30000
Treatments
Control group
Healthy participants with a negative colonoscopy result
Colorectal cancer
Participants with colorectal cancer diagnosis confirmed by colonoscopy
Low-risk polyps
Participants with positive colonoscopy and detection of low-risk adenomas
High-risk polyps
Participants with positive colonoscopy and detection of high-risk adenomas
Related Therapeutic Areas
Sponsors
Collaborators: CUF Tejo Hospital, Hospital CUF Descobertas, Lisbon, Portugal, Hospital da Luz Lisboa, Portugal
Leads: Gulbenkian Institute for Molecular Medicine

This content was sourced from clinicaltrials.gov