Colorectal Cancer Screening for Persons With a Positive Family History—Evaluation of the FARKOR Program for the Secondary Prevention of Colorectal Cancer in Persons Aged 25 to 50.

Background: Persons with a positive family history of colorectal cancer (CRC) are more likely than others to develop CRC and are also younger at the onset of the disease. Nonetheless, the German Federal Joint Committee (G-BA, Gemeinsamer Bundes - ausschuss) recommends screening all persons aged 50 and above regardless of their family history. FARKOR was a project supported by the Innovation Fund of the G-BA to study the feasibility, efficacy, and safety of a risk-adapted early detection program for CRC among persons aged 25 to 50 without any specific past medical history.

Long-term benefits and harms of early colorectal cancer screening in German individuals with familial cancer risk.

Individuals with a family history of colorectal cancer (CRC) may benefit from early screening with colonoscopy or immunologic fecal occult blood testing (iFOBT). We systematically evaluated the benefit-harm trade-offs of various screening strategies differing by screening test (colonoscopy or iFOBT), interval (iFOBT: annual/biennial; colonoscopy: 10-yearly) and age at start (30, 35, 40, 45, 50 and 55 years) and end of screening (65, 70 and 75 years) offered to individuals identified with familial CRC risk in Germany. A Markov-state-transition model was developed and used to estimate health benefits (CRC-related deaths avoided, life-years gained [LYG]), potential harms (eg, associated with additional colonoscopies) and incremental harm-benefit ratios (IHBR) for each strategy.

Secondary resistance to anti-EGFR therapy by transcriptional reprogramming in patient-derived colorectal cancer models.

Background: The development of secondary resistance (SR) in metastatic colorectal cancer (mCRC) treated with anti-epidermal growth factor receptor (anti-EGFR) antibodies is not fully understood at the molecular level. Here we tested in vivo selection of anti-EGFR SR tumors in CRC patient-derived xenograft (PDX) models as a strategy for a molecular dissection of SR mechanisms.

Methods: We analyzed 21 KRAS, NRAS, BRAF, and PI3K wildtype CRC patient-derived xenograft (PDX) models for their anti-EGFR sensitivity.

Incorporation of Multiple Sources into IT - and Data Protection Concepts: Lessons Learned from the FARKOR Project.

The IT- and data protection concept of the FAmiliäres Risiko für das KOloRektale Karzinom (FARKOR) project will be presented. FARKOR is a risk adapted screening-project in Bavaria, Germany focusing on young adults with familial colorectal cancer (CRC). For each participant, data from different sources have to be integrated: Treatment records centrally administered by the resident doctors association (KVB), data from health insurance companies (HIC), and patient reported lifestyle data.

Evaluating the effects of a risk-adapted screening program for familial colorectal cancer in individuals between 25 and 50 years of age: study protocol for the prospective population-based intervention study FARKOR.

Background: Colorectal cancer (CRC) is the second most common malignant disease and the second most common cause of cancer death in Germany. Official CRC screening starts at age 50. As there is evidence that individuals with a family history of CRC have an increased risk of developing CRC before age 50, there are recommendations to start screening for this group earlier.

Evaluation of the IT Infrastructure of the RESIST Study with the Evidence-Based CIPROS Checklist.

Efficient and powerful information systems are substantial to perform medical research projects successfully. Especially, translational medicine poses specific challenges to the corresponding IT infrastructure. The RESIST study is a translational research project in oncology where xenografts inform about patients second-line treatment.

Data for the elaboration of the CIPROS checklist with items for a patient registry software system: Examples and explanations.

The data presented relates to the publication "Enhancing Requirements Engineering for Patient Registry Software Systems with Evidence-based Components" (Lindoerfer and Mansmann, 2017) [1], which describes the strategy behind the development of the CIPROS checklist. This manuscript also compares CIPROS with general requirements specification templates, and standards. The data is shortly described in Section 2.

Enhancing requirements engineering for patient registry software systems with evidence-based components.

Introduction: Patient registries are instrumental for medical research. Often their structures are complex and their implementations use composite software systems to meet the wide spectrum of challenges. Commercial and open-source systems are available for registry implementation, but many research groups develop their own systems.

IT Infrastructure of an Oncological Trial Where Xenografts Inform Individual Second Line Treatment Decision.

Translational clinical research is often characterized by a unidirectional information flow from clinical to molecular data by using phenotypes to elucidate molecular disease processes. Here we present the RESIST study which uses xenograft information for individual treatment decisions after resistance to a specific anticancer treatment establishing a bidirectional information flow between patient and molecular biology. The paper discusses the specific challenges related to the IT infrastructure for such bidirectional translational projects and proposes solutions.

Proposing an Evidence-Based Strategy for Software Requirements Engineering.

This paper discusses an evidence-based approach to software requirements engineering. The approach is called evidence-based, since it uses publications on the specific problem as a surrogate for stakeholder interests, to formulate risks and testing experiences. This complements the idea that agile software development models are more relevant, in which requirements and solutions evolve through collaboration between self-organizing cross-functional teams.

Treatment and outcome of 2904 CML patients from the EUTOS population-based registry.

The European Treatment and Outcome Study (EUTOS) population-based registry includes data of all adult patients newly diagnosed with Philadelphia chromosome-positive and/or BCR-ABL1+ chronic myeloid leukemia (CML) in 20 predefined countries and regions of Europe. Registration time ranged from 12 to 60 months between January 2008 and December 2013. Median age was 55 years and median observation time was 29 months.

A Comprehensive Assessment Tool for Patient Registry Software Systems: The CIPROS Checklist.

Background: Patient registries are an important instrument in medical research. Often their structure is complex and their implementation uses composite software systems to meet the wide spectrum of challenges.

Objectives: For the implementation of a registry, there is a wide range of commercial, open source, and self-developed systems available and a minimal standard for the critical appraisal of their architecture is needed.

The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European Countries.

This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months.

CIPROS--a checklist with items for a patient registry software system.

Patient registries are an important instrument in medical research. Their implementation uses complex software systems to meet the wide spectrum of challenges. There is a wide range of systems available and a critical appraisal of their architecture is needed.

The EUTOS prognostic score: review and validation in 1288 patients with CML treated frontline with imatinib.

The introduction of tyrosine kinase inhibitors (TKI) in the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) has revolutionized the outcome, but the prognosis of the disease is still based on prognostic systems that were developed in the era of conventional chemotherapy and interferon (IFN)-alfa. A new prognostic score including only two variables, spleen size and basophils, was developed for the prediction of complete cytogenetic response (CCyR) and progression-free survival (PFS). The score was based on a large series of patients who were enrolled in prospective multicenter studies of first-line imatinib treatment.

Predicting complete cytogenetic response and subsequent progression-free survival in 2060 patients with CML on imatinib treatment: the EUTOS score.

The outcome of chronic myeloid leukemia (CML) has been profoundly changed by the introduction of tyrosine kinase inhibitors into therapy, but the prognosis of patients with CML is still evaluated using prognostic scores developed in the chemotherapy and interferon era. The present work describes a new prognostic score that is superior to the Sokal and Euro scores both in its prognostic ability and in its simplicity. The predictive power of the score was developed and tested on a group of patients selected from a registry of 2060 patients enrolled in studies of first-line treatment with imatinib-based regimes.