19 March 2025
In the month dedicated to Colorectal Cancer (CRC) Awareness, the CARE-CRC clinical study began - a study which the main objective is to identify intestinal microbiome biomarkers associated with CRC, prognosis and response to treatment, and ultimately improve patients' health and lead to the development of public health strategies.
Coordinated by Professor Ana Santos Almeida, principal investigator of a translational laboratory at the GIMM Foundation - Gulbenkian Institute for Molecular Medicine (GIMM-CARE), this study will take place at the Champalimaud Foundation, in collaboration with Dr. José Azevedo, surgeon of the Colorectal Cancer Group of the Digestive Unit of the Champalimaud Clinical Center, and at the Hospital de Santa Maria, with the participation of oncologists Professor Luís Costa and Dr. André Mansinho.
Colorectal cancer represents a significant public health challenge in Portugal, being the most prevalent type of cancer and the second leading cause of cancer death in the country. According to recent data, more than 10,500 new cases of CRC are recorded annually, resulting in an average of 12 deaths per day. In recent years, there has been a worrying increase in the incidence and mortality from CRC in young people, with the frequency of early-onset colorectal cancer (EoCRC) rising from 5% to 10% of all new CRC cases in the space of 10 years. By 2030, an increase of over 140% is expected.
Only 25% of CRC cases have a family history, suggesting that environmental and lifestyle factors play a significant role. Diets low in fiber and high in saturated fats and processed meats, obesity, alcohol consumption, physical inactivity, stress, and chronic gastrointestinal inflammation are thought to account for 70–90% of CRC risk. According to the World Cancer Research Fund, 47% of all CRC cases could be prevented with lifestyle changes, particularly in diet and increased physical activity. These factors are also strongly associated with changes in the gut microbiome, which differs significantly between CRC patients and healthy individuals. The gut microbiome, the community of one billion microorganisms that inhabit the human intestine, can modulate tumor progression by producing metabolites (substances resulting from metabolism) that influence immune responses or create anti-tumor environments, thus making it a promising target for the detection and prevention of CRC.
The CARE-CRC study will recruit 400 patients aged 40 to 74 years with a recent diagnosis of CRC who have not yet started treatment. Using faecal samples collected at diagnosis, immediately after treatment and three years later, the gut microbiome will be analysed by metagenomic sequencing, which will allow identifying correlations between microbial composition and clinical outcomes, such as response to treatment and survival.
This strategy aims to develop a non-invasive diagnostic tool, identifying biomarkers that allow improving early detection of CRC, personalising treatments and reducing healthcare costs.
Based on an Artificial Intelligence platform, the results will also provide insights into the interaction between lifestyle, diet and microbiome changes in the progression of CRC, which may lead to the development of personalised preventive strategies and, ultimately, better therapeutic results.
https://clinicaltrials.gov/study/NCT06734156
https://care.gimm.pt/
The GIMM-CARE Translational Microbiome in Health and Disease Laboratory is composed of a dynamic, interdisciplinary, and highly collaborative team of clinical microbiologists, computational biologists, nutritionists, and gastroenterologists. The laboratory is dedicated to exploring the potential of the microbiome to revolutionise the therapeutics of colorectal cancer. Our mission is to develop innovative microbiome-based diagnostic and biotherapeutic tools to promote health.
Since 2013, the Colorectal Cancer Group - Digestive Unit of the Champalimaud Clinical Center has focused on the treatment of colon and rectal cancer, adopting a multidisciplinary approach. The team uses advanced techniques in radiation oncology, radiology, and high-precision robotic surgery, aiming to minimise the impact on patients' quality of life while maintaining excellent oncological outcomes. With the aim of developing innovative therapeutic options that translate into better outcomes for patients, the group works collaboratively with researchers from the Champalimaud Foundation as well as with external groups.
