Pancreatic cancer will become the 2nd leading cause of cancer-related death by the year 2030. There are different standards, therapies and settings in the European countries. Furthermore, there is no target-oriented treatment for patients with pancreatic cancer. “We treat all patients with Pancreatic cancer alike”, Professor Alfredo Carrato said, “but there are different groups and an urgent need to identify these groups by implementation of registries and biobanks”. Implementing efficient data collection and a European pancreatic cancer registry is the main objective of the Registries Work Stream of Pancreatic Cancer Europe, the European multi-stakeholder platform on pancreatic cancer.
Around 100.000 people are diagnosed with pancreatic cancer in Europe each year. Most of them die in less than one year. There is a high medical need and a strong need for public policy support as no plans are dedicated to pancreatic Cancer in the European Union.
Pancreatic Cancer Europe is a European multi-stakeholder platform aiming to bring together experts from all over Europe with a common interest and willingness to improve care for patients with pancreatic cancer. The main objective of the Registries Work Stream is to implement efficient data collection and pancreatic cancer registries to improve data collection, diagnosis, treatment and outcome of Pancreatic cancer patients. “We are trying to implement a registry in Europe, feasible in practice and of a high quality level“, Professor Alfredo Carrato said at the PancreOS kick-off meeting in Madrid, Spain, that was held on 17 March 2016.
“The main objective of the project PancreOS (Pancreatic Cancer Overall Survival Registry EUROPE) is to fill the gap of the lack of organized data collection in pancreatic cancer, to ensure appropriate sustainable collection of clinical data, comparability issues, exchange of data and information within and between European countries”, Prof. Carrato explained. The cooperation with EU-wide initiatives, such as the European Network of Cancer Registries, and the support of national population-based registries is a further objective.
PancreOS is intended to be an agreement on the minimum data collection standards from pancreas cancer. Prof. Carrato: “We will provide these data to be used by all members for the benefit of our patients”. There will be a permanent and sustainable online standardized exchange of data through the use of common datasets to identify different groups of patients and areas of improvement.
The Spanish Cooperative Group on Digestive Tract Tumors (TTD) has finished a pilot registry called PancreOS Spain. This project has collected a comprehensive set of prospective data from pancreatic cancer patients at any stage of the disease. It tested the feasibility of this registry in daily clinical practice and can be a good example of what can be done at EU level for pancreatic cancer registries.
PancreOS Spain collected datasets of 50-70 Patients in 7 Centres. Patients were enrolled from July to October 2015. The Clinicians were asked to answer a questionnaire containing informed consent, socio-demographic data, cancer family history, patient prior medical history, disease diagnosis, diagnostic procedure, surgery, radiotherapy, chemotherapy, outcome and patient status.
Dr. JJ Garcia presented some preliminary results from 67 patients. One of the main results was that weight loss was one of the most common symptoms in 53% of the patients. Around 47% suffered from abdominal pain, about 22% had coluria and 20% hypo-acolia. 15% suffered from nausea/vomiting or asthenia, another 10% form anorexia and 9% had back pain. About 30% had prior onset of diabetes, 15% other neoplasms.
Main stage was stage 4 (46%), 36% stage 3, 15% stage IIb, 3% stage Ib, 24% of data were missing. 15 Patients were potentially unresectable, 9 Patients potentially resectable, 3 clinically resectable. Diagnosis was made in 85% by pathology, and by imaging in 15%. Median days from 1st symptom to diagnosis was 46 days.
The investigators came to the conclusion that adjustments of the questionnaire were required as the data collection was still too time-consuming for clinicians in the daily practice.
Pancreatic Cancer Europe will help endorsing and expanding the registry to more countries in Europe. The simultaneous start of PancreOS in several European centres will ensure that the methodology (data collection, software use, data analysis and ethics) will by directly comparable. There already exists a consensus on variables for data collection (open for discussion).
For data sharing, high quality data are required, and a multidisciplinary team should be involved in data collection. The data will be anonymised and encrypted to ensure the privacy of the data subjects’ confidentiality. As the implementations and interpretations of the data protection directive vary between countries, data protection authorities in each country have to be contacted.
To become a partner of PancreOS certain requirements have to be met: Commitment of 2-3 years’ participation and exhaustiveness of case recruitment. Ethical approval is requested, depending upon local rules. Work under the PancreOS coordinating centre guidance. Data quality controls (complete and consistent data are needed). An established collaboration with population-based registries and the involvement of a multidisciplinary team are recommended.
To become a PancreOS collaborator contact Alfredo Carrato and Nùria Malats. Nùria Malats, MD, MPH, PhD EUPancreas COST Action Chair Spanish National Cancer Research Center (CNIO) Melchor Fernández Almagro 3 28029 Madrid, Spain (firstname.lastname@example.org) Alfredo Carrato, MD, PhD Professor & Director, Medical Oncology Department Ramon y Cajal University Hospital, Alcala University, Madrid, Spain Director, Ramon y Cajal Institute for Health Research IRYCIS email@example.com
Pancreatic Cancer Europe is a European multi-stakeholder platform which aims are bringing together experts from all over Europe including academics, physicians, politicians, patient groups, journalists and industry with a common interest and willingness to improve care for patients with pancreatic cancer. Pancreatic Cancer Europe was initiated by a Call to Action launched in July 2014 by 4 Members of the European Parliament (MEPs) from 3 different Member States and 3 different political groups, and co-signed by 32 additional MEPs. Key Work Streams of the Platform are Awareness, Diagnosis, Registries, and National Support.
Pancreatic Cancer Europe is becoming a legally constituted association operating from Brussels.