March is Colorectal Cancer (CRC) Awareness Month, raising awareness of the second most common type of cancer, which accounts for 10% of all cancer cases worldwide. By 2030, CRC – also known as bowel cancer – will be the biggest threat to life for people aged 50 and under.
Environmental exposures – such as the low-fibre, high-fat nature of a typical Western diet – spark approximately 90% of such cases, in which harmful precursor lesions develop in the colon over an extended period of time.
Catching the cancer early, however, could help avoid fatal outcomes.
Screenings can identify the presence of any precursor lesions in the colon and alert patients to any other signs and symptoms. These may include:
- bloating, fullness and cramping
- blood in the stool
- changes in bowel habits
- frequent gas pains
- narrower stools than usual
- persistent tiredness
- rectal bleeding
- unexplained weight loss.
At Frontier Science Scotland (FSS), we’re pleased to have collaborated on numerous trials related to colorectal cancer screening.
Among these was the NordICC trial: the first study to investigate the efficacy of colonoscopy screenings versus no screenings – addressing the knowledge gap in understanding its real-world effectiveness as a preventative tool.
“As someone who is at an increased risk of bowel cancer, I am extremely proud to work for an organisation who, alongside its key partners, champions this research and seeks to find the most effective therapies,” says Eric Riley, Head of Clinical Trials Development & Engagement at FSS.
Study details
The NordICC study was a randomised control trial that analysed data from over 84,000 participants (male and female aged 55 to 65) across the Netherlands, Norway, Poland and Sweden.
Between 2009 and 2014, two population groups were examined: one study group that was offered a one-time colonoscopy screening and one control group that maintained their current standard of care.
Data that we managed during this trial came from various sources. This included non-eCRF data such as control patient data, invitations, population registries, private examinations, questionnaires and randomisation data.
“Consolidating multiple electronic Case Report Form (eCRF) databases and unstructured Real World Data (RWD) into a valuable research dataset was a complex task,” says Eric Smith, Senior Database Programmer at FSS. “But creating this resource enabled us to enhance our understanding of colorectal cancer screening.”
Our collaboration on NordICC and areas of responsibility
In partnership with the University of Oslo, FSS held responsibility for trial data management and cleaning processes. After inheriting the original Case Report Form (CRF) system from a third party – which contained five databases – we used Coloreg, an application for Electronic Data Capture (EDC), to create secure remote access for our sites via our server. Team members, therefore, were no longer restricted to using the single designated hospital PC.
Throughout the trial, some specific tasks included:
- merging the five non-identical databases into a single consolidated database
- removal of personally identifiable information (PII)
- data standardisation across multiple languages, e.g. code lists
- streamlining the invitation process for partners.
Key outcomes
Colonoscopy screenings led to higher detection rates in the proximal and distal colon. The group that underwent a screening experienced a 31% reduction in colorectal cancer instances and a 50% reduction in deaths related to colorectal cancer.
In a median (10-year) follow-up, new data suggested that one case of colorectal cancer prevention was possible for every 455 invitations sent.
The study tested the efficacy of screenings in countries that already routinely prescribe this practice. In regions where this is not the case, such as the US, the effectiveness of such interventions may prove less impactful given the practice is less culturally accepted.
Results of the original investigation were published in JAMA Internal Medicine in 2016: Population-Based Colonoscopy Screening for Colorectal Cancer: A Randomized Clinical Trial.
Further Reading
- Frontier Science Scotland: NordICC
- Fight Colorectal Cancer: Facts & Stats
- Pfizer: Colon Cancer
- National Library of Medicine: Young-onset Coloerectal Cancer: A Review
- World Health Organization: Colorectal Cancer
