Implementing FAIR data for cancer research - the Dutch PLCRC study

Setting up a large-scale prospective clinical study is difficult at the best of times. Obtaining ethical approval, enrolling patients, collecting their data, obtaining biobank samples, and curating a database to handle all the information invariably takes a lot of time, effort and budget. How much easier it would be if someone had already done a lot of that work for you! Researchers investigating better treatment and outcomes for patients with colorectal cancer are now in that fortunate position. Geraldine Vink and Robert Coebergh van den Braak, program managers in the Prospective Dutch Colorectal Cancer Cohort (PLCRC) explain how it’s being achieved.

12 July 2017

Geraldine Vink Robert Coebergh van den Braak


Interview with Geraldine Vink and Robert Coebergh van den Braak
Program Managers in the Prospective Dutch Colorectal Cancer Cohort

The Dutch Colorectal Cancer Group’s Prospective Dutch Colorectal Cancer cohort (PLCRC) initiative doesn’t focus on specific research into the causes, treatment or outcomes of colorectal cancer. Instead, it focuses on collecting and curating the data and biobank material that other research groups will need in order to perform observational and interventional studies that address those topics. The long-term nature of the PLCRC study, which aims to enroll around 10,000 colorectal cancer patients per year and collect their data from primary diagnosis to death, will therefore facilitate a great deal of future research. Its database is being hosted on the Lygature managed TraIT/tranSMART platform.

“When a hospital doctor obtains a patient's agreement to participate in the cohort, they can enroll the patient via a web-based enrollment system managed by University Medical Center Utrecht,” says PLCRC program manager Geraldine Vink of the Netherlands Comprehensive Cancer Organization (IKNL). “By giving informed consent, the patient agrees to let us access their data in the Netherlands Cancer Registry, store resected tissue from their tumor, collect blood samples, and periodically ask them to fill in questionnaires."

Putting tranSMART to work

Twenty-five cancer centers in the Netherlands are already enrolling patients, with a further 25 in the process of getting approval from the medical ethical committee. Subject to these approvals being granted, it means that by the end of the year over 60% of the Netherlands cancer centers will be participating.

“Framing the patient's informed consent as broad as we did and obtaining ethical approval upfront means that if someone wants to answer a research question using biobank material, clinical data or questionnaire responses from the PLCRC cohort, they won't have to go back to an ethical board to ask for permission again,” says Robert Coebergh van den Braak of Erasmus MC University Medical Center, Rotterdam. “More importantly, they won't have to set up their own biobank, start filling it, and then wait five or six years for sufficient follow-up data to accumulate before they can start analysing it.  Instead, they can start right away, because we’ve already done most of the work for them.”

When the PLCRC study wanted a central place to store the accumulated clinical and questionnaire data, they turned to TraIT's tranSMART implementation.

“Periodically, we get a clinical data dump from IKNL for all new patients who have enrolled in the cohort, and upload it to tranSMART, from where de-identified data can be made available to participating research groups,” says Robert. “But the real beauty of the system is that those research groups can then upload their own results back to the database.  For example, if someone generates next-generation sequencing data for a set of patients in the PLCRC cohort, they can upload that data to tranSMART so that it’s integrated into the database and available for the next set of researchers to use. So the database is constantly being enriched, not just in terms of the number of enrolled patients, but also in terms of accumulated knowledge.”

Fostering collaboration

According to Geraldine, this concept of data sharing and enrichment fits perfectly with the ambitions of the Dutch Health-RI and BBMRI-NL initiatives, in which IKNL and TraIT are also involved.

“What Health-RI and BBMRI-NL are aiming to establish is a research infrastructure in the Netherlands that brings research groups together so that research is not fragmented - no little groups doing their own research, not talking to each other, and each one finding new solutions for the same problem,” she says. “You need one infrastructure that everyone is involved in so that you collect the data once and use it multiple times. And that’s what we would like to achieve – a single umbrella for research on colorectal cancer in the Netherlands – because it makes research a lot faster and a lot cheaper, and benefits patients more quickly.”

"It’s ridiculous that in a small country like the Netherlands, the same data-points for each patient are still entered five or maybe ten times in different databases – that research groups are still trying to put together cohorts and collect the data themselves – when the Netherlands Cancer Registry already has it," comments Robert. "So what we’re doing is really about making the data FAIR - Findable, Accessible, Inter-operable, and Re-usable. And it’s best practices like TraIT and BBMRI-NL that are enabling us to do it."

Those best-practices are already putting the Netherlands at the forefront of translational medical research.

“We have the advantage in the Netherlands that we are geographically small enough to work together, yet we have a large enough population to recruit the number of patients we need to do our research,” says Geraldine.