The LALUCA registry is based in Vienna, the capital city of Austria. Vienna has a population of approximately 2 million inhabitants, who have free access to high-quality healthcare [8]. Between 2018 and 2020, 1028 cases of tracheal and lung cancer on average have been reported for Vienna to the Austrian National Cancer Registry [9]. The Departments of Respiratory and Critical Care Medicine of the Klinik Floridsdorf and the 2nd Department of Internal Medicine with Pulmonology of the Klinik Ottakring facilitate diagnosis and treatment for a large number of lung cancer patients in Vienna. Within this patient cohort, the LALUCA registry is recruiting patients for study participation.

The purpose of this project is to set up a clinical platform to collect representative real-world data on lung cancer management in Austria. We aim to evaluate clinical characteristics, diagnostic and treatment modalities, as well as outcome of unselected patients in real-life practice. In contrast to data of clinical trials, this registry is able to show data on the whole lung cancer patient population including information on older and comorbid patients. This registry focuses specifically on the collection of representative data on molecular biomarker testing and NGS data of patients before the start of first-line treatment, including information on rare mutations and clinical consequences of NGS testing. Another equally relevant objective of this registry is to assess indicators of the quality of care in patients with lung cancer such as timeliness of diagnosis and first treatment application as well as frequencies, modalities and sequences of imaging and treatment. In this respective, in an ongoing investigation we assess the implementation of biomarker testing by analyzing testing rates, timeliness and areas of improvement in molecular testing. By evaluating the incorporation of guideline recommendations, we hope to reveal challenges in molecular testing and highlight areas of improvement. Moreover, investigations of specific therapeutic settings are planned to analyze outcomes in a real-world patient cohort, thereby complementing results from cancer trials and adding information for the development of guidelines and policy decisions.

The LALUCA registry is registered at ClinicalTrials.gov (NCT04733430) as an observational, prospective, multicenter clinical registry. Overseen by the Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, the LALUCA registry is run by a multidisciplinary team, including pulmonologists, pathologists, oncologists, thoracic surgeons, radio-oncologists, clinical scientists, system engineers and several data entry specialists. The registry is designed as a custom web-based platform created by celsius37TM (celsius37.com AG, Mannheim, Germany) using the push method of data extraction and input by trained staff. Data entry personnel (DEP), each working with a separate user account, extract detailed information from electronic health records (EHR) and transform running text into specific variables that are manually documented into standardized electronic case report forms (eCRF). The eCRF is filled out on the LALUCA website in accordance with good clinical practice (GCP) guidelines, as well as with additionally created LALUCA guidelines ensuring the accuracy, legibility, completeness and timeliness of data documentation.

All patients, who are diagnosed with lung cancer at one of the two centers, are offered participation. Patients are eligible for inclusion if they have a histologically or cytologically confirmed lung cancer, are over the age of 18 years, and sign a consent form. Additionally, patients need to be able to understand and complete the patient reported outcomes assessment instruments. Recruitment for patients started in November 2020 and is ongoing.

The study was reviewed and approved by the ethics committee of Vienna (EK-20-061-VK). This project is supported by the following industry partners: Amgen, AstraZeneca, Bristol Myers Squibb, Böhringer, Eli Lilly Oncology, Gilead, Janssen, Merck Group, Merk Sharp&Dohme, Novartis, Pfizer, Roche, Sanofi, and Takeda Oncology. Sponsors had no influence on design, methodology, or parameter selection of the registry.

After patients have signed the informed consent form, the LALUCA team is given access to their medical health records relevant to the management of lung cancer. Additionally, patients are required to fill out a case history questionnaire. To enable DEP to gather all relevant information for the eCRF in the LALUCA registry, specifically tailored forms are available to the physicians in either digital or physical form for patient documentation. The collection of patient information starts at the first consultation and includes the patient’s self-reported questionnaires, tailored forms from the physicians, as well as imaging records, pathological, histological and cytological reports from the EHR. All obtained data variables organized by category are shown in the Table 1. As an example for the documentation of specific elements on the platform, collected data items for molecular pathology are displayed in Table 2.

To guarantee a sufficiently high quality of the data, various measures were implemented to ensure data accuracy, completeness, capture, data standardization and timeliness [10]. First, all DEP are trained by senior staff members and participate in a monthly training seminar to update their knowledge and to be equipped with all tools necessary to abstract relevant information from the EHR and enter it into the eCRFs. To enhance data accuracy and to reduce the possibility of interpretative errors, the LALUCA guidelines were created containing all the data items, codes and definitions assessed in the registry and therefore serve as a data dictionary during the input process. All DEP have access to the LALUCA guidelines to allow a uniform interpretation of EHR and input into the data registry. Second, the tailored forms filled out by physicians serve the purpose of inputting complete information into the LALUCA registry. Third, input variables are mostly standardized and seldom allow free text. Finally, quality assurance monitoring is carried out by a clinical monitor throughout the whole study and data quality checks are performed periodically using custom-made Python scripts including completeness and extensive plausibility checks, as well as regular statistical reports of the data sets. In cases of discrepancies or missing values, the study sites are contacted to make any necessary changes to the data.

After enrolment, patient data are assessed every 6 months for a follow-up status and an update of ongoing treatment. In cases of loss to follow-up, the insurance provider is contacted for information about the patient’s survival status.