Colorectal cancer is the most common cancer and the second with the highest mortality rate in Spain.

The Consellería de Sanidade of Galicia (Galician Ministry of Health) and the biotechnology company GoodGut, part of the HIPRA group, are initiating a pilot study of an innovative test, based on the quantitative PCR technique, to evaluate its possible integration into the Galician Colorectal Cancer Screening Programme. Previous studies have shown that, by identifying a bacterial signature specific to colorectal cancer, the test developed by GoodGut can increase efficiency in the diagnosis of the disease¹.

This pilot study will be carried out in Ourense, within the framework of the Galician Colorectal Cancer Screening Programme (PGDPCC) led by the General Directorate of Public Health. This study aims to promote an improvement in the efficiency of colorectal cancer screening programmes.

Joaquín Cubiella, endoscopist and renowned gastroenterologist of the Complexo Hospitalario Universitario de Ourense, as well as leading the Digestive Oncology Research Group of Ourense, an external collaborating group of IIS Galicia Sur, is the principal investigator.

Currently, for the early diagnosis of colorectal cancer, the TSOHi (Stool Occult Blood Immunochemical Test) is used as a non-invasive test to identify individuals requiring colonoscopy, to confirm the diagnosis and eliminate possible high-risk lesions. This study, within the framework of the PGDPCC, will evaluate the use of the GoodGut test as a second-line test. The study will offer participation to 1,200 people with a positive TSOHi screening result. Participants will follow the usual circuit and will be scheduled for the corresponding diagnostic colonoscopy at the Programme Unit located at the University Hospital of Ourense. In parallel, with their consent, the initial sample collected with the TSHOi will be used for subsequent reanalysis with the GoodGut test at the facilities of the Digestive Oncology Research Group of Ourense, being able to evaluate the added value of incorporating it as an additional test to refer patients for colonoscopy.

The GoodGut test is expected to significantly improve the accuracy of the current diagnostic algorithm and reduce the number of colonoscopies by around 20%². In this sense, its implementation could help to optimise the use of resources, as well as alleviate the burden, both in terms of assistance and economics, on the health system. Its incorporation would require minimal changes in screening protocols, as it is based on the widely used PCR technique and can be performed on the same collector that is currently used to analyse TSOHi.

This pilot study in Galicia will be conducted in parallel to the one being carried out in Catalonia, both being key to validate the previous results obtained with more than 3,000 patients. In addition, it is expected to obtain data supporting the efficacy, efficiency, effectiveness and health utility of the test, as well as its economic impact on the health system.

About colorectal cancer and its diagnosis

Colorectal cancer is the most common cancer and the second with the highest mortality in Spain³. Treatment is more effective when detected early4, which can lead to 94% survival at 5 years in cases diagnosed early, in contrast to 14% in cases diagnosed in advanced stages⁴. For this reason, most countries offer prevention measures through screening programmes aimed at the medium-risk population, in Spain, adults aged 50-70 years⁵.

Screening programmes are preventive strategies that seek to identify and diagnose diseases early in asymptomatic individuals, when they are still latent or in early stages, allowing the application of interventions that improve the prognosis and reduce the burden of the disease in the population.

As Carmen Duran Parrondo, General Director of Public Health at the Galician Ministry of Health, points out: "The role of public health through screening programmes is essential for the prevention, early detection and control of diseases (such as colorectal cancer), as well as ensuring equity and accessibility throughout the target population".

In 2014, population-based screening for colorectal cancer was incorporated into the Spanish health system's service portfolio, specifying that the autonomous communities would have 10 years (2024) to invite almost 100% of the Spanish target population to participate. By 2019, the invitation coverage of the PGDPCC reached the entire target population⁸.

Galicia is one of the autonomous communities in Spain with the highest incidence of colorectal cancer⁷. However, as the General Director of Public Health points out, between 2013 and 2021 the overall participation rate is 45.42%⁶, with significant differences between men and women (men participate less and yet are at greater risk).

For this reason, it is paramount to increase participation rates through actions and awareness-raising campaigns, among other measures, to increase the number of cases detected early and reduce the prevalence and mortality associated with colorectal cancer. However, the increasing coverage and participation in screening programmes would increase the demand for care resources and the need for more colonoscopies.

The Consellería de Sanidade and GoodGut believe in the importance of supporting systems that optimise resources to achieve these improvements in a way that is affordable for the health system. The synergy between both parts, together with the involvement of the health specialists who lead the screening programmes in the General Directorate of Public Health, is key to promoting initiatives such as this one, in order to improve the impact of screening programmes on population health.

In short, the implementation of the GoodGut test could be a very relevant solution to achieve a health policy that increases the early detection of colorectal cancer and, at the same time, optimises the resources available in the health system.

About GoodGut

The biotech company GoodGut, acquired by HIPRA in 2021, is focused on the development of diagnostic support tests and treatment products for digestive diseases based on the analysis and modulation of the gut microbiota, with the aim of introducing a new paradigm in clinical standards to improve the quality of life of people with compromised digestive health.

GoodGut was created in 2014 as a spin-off of the University of Girona (UdG) and the Dr.. Josep Trueta Institute for Biomedical Research of Girona (IDIBGI) to transform the knowledge obtained into innovative solutions with a high impact on society. It has already developed three diagnostic tests and another three products are in study phase.

References

1. Malagón M, Oliver L, Ramió-Pujol S, Guardiola J, Balaguer F. Returning to endoscopy normality through the support of a new non-invasive faecal test based on microbial signatures. Digestive and Liver Disease. 2021; 53(12):1666–1668
2. Malagón M, Ramió-Pujol S, Serrano M, Amoedo J, Oliver L, Bahí A, et al. New fecal bacterial signature for colorectal cancer screening reduces the fecal immunochemical test false-positive rate in a screening population. PLoS ONE. 2020;15(12).
3. Malagón M, Alwers E, Oliver L, et al. Clinical performance study of a faecal bacterial signature test for colorectal cancer screening (Manuscript Submitted to the N Eng J Med).
4. El cáncer en España, datos y estadísticas. (s. f.).https://www.epdata.es/datos/cancer-espana-datos-estadisticas/289
5. Cancer Today [Internet]. 2020 [cited 2022 Jan 3]. Disponible en: https://gco.iarc.fr/today/home
6. Andermann A, Blancquaert I, Beauchamp S, Déry V. Revisiting Wilson and Jungner in the genomic age: a review of screening criteria over the past 40 years. Bulletin of the World Health Organization. 2008;86(4):317–9.
7. Ep. (2023, 30 marzo). Galicia, entre las autonomías con mayor incidencia de cáncer de colon, con 2.925 nuevos casos en 2022. El Correo Gallego. https://www.elcorreogallego.es/galicia/2023/03/30/galicia-autonomias-mayor-incidencia-cancer-colon-85402068.html
8. Programa galego de detección precoz do cancro colorrectal. (s/f). Sergas.es. Retrieved on July 12, 2023: https://www.sergas.es/Saude-publica/Documents/536/Informe_anual_2013_2021_PGDPCC.pdf