University of Latvia organised ESF project “Early Tumour Diagnostics and Prevention Multidisciplinary Research Group” No.2009/0220/1DP/188.8.131.52.0/09/APIA/VIAA/016 (henceforth “ESF Project). One of the main goals of this project was biomarkers detection in order to diagnose tumours and risk conditions. In order to achieve this, it was planned to develop cooperation both with Latvian and international scientific institutions. Within the scope of the project, several screening studies were conducted (including, screening pilot study and sociological studies). Project activities are associated with ensuring project publicity and sustainability. Scientific sustainability is one of the project’s results. According to ESF Project’s screening results and conclusions, in 2012, initial planning and development work of the GISTAR study begun. The other purposes of GISTAR study are ensuring scientific sustainability of previous results, as well as the planned international cooperation. All activities regarding GISTAR study within the scope of ESF Project relate to ESF project “Early Tumour Diagnostics and Prevention Multidisciplinary Research Group”. GISTAR – study on gastrointestinal cancer prevention, by timely detecting atrophic gastritis and colon or rectal mucosa damage. The purpose of this study is to identify and prove efficacy of new diagnostic methods in timely gastric and colorectal cancer detection and prevention in high prevalence regions. The study protocol describes gastric and colorectal cancer prevalence and tendencies in Latvia and Eastern Europe. Eastern Europe is a high prevalence and risk region; therefore, there is a real need to continue work on timely diagnostics of gastric and colorectal cancer according to international guidelines. Colorectal screening data for Latvia (within the scope of the ESF Project) also demonstrate a need for further studies. The concept of the study is to engage 40-64 year olds and to detect biomarkers for them, then to follow up those persons for 15 years in order to compare mortality rates in test and control group. Therefore, with ESF Project, there is information based on patient material, the most essential survey questions, models etc. – all that can be used in GISTAR and similar projects, because ESF Project requires that the results should be available for public.
1. Development of GISTAR protocol for further gastrointestinal cancer studies on larger scale. Protocol was prepared in 2012 by international researcher group under supervision of the University of Latvia. The protocol describes non-invasive early diagnostic methods for gastric and colon cancer, which, in case of their efficiency and positive results in hypothesis testing, might be introduced in Eastern Europe. The study participants will be randomised into two groups. Both groups will be surveyed and there be a different case control follow-up algorithm for each group. In order to ensure sustainability of the project on international scale, GISTAR study protocol and all related documents are prepared mainly in English. The study protocol was prepared and submitted to the Ethics Committee at International Agency for Research on Cancer (IARC), which gave mainly positive decision and recommendations for improving the protocol.
2. A questionnaire was prepared – with 27 pages and 11 question blocks (personal data, social and demographic data, employment data, data on tobacco and alcohol use, physical activity and life-style factors, eating habits, family history, medical history, questions on women health), as well as body measurements and mark for receiving diagnostic test. Questions in the questionnaire were selected based on ESF Project’s screening results, as well as international guidelines. Questionnaire is in three languages (Latvian, English and Russian) and it includes additional material in form of seven visual aids cards. In order to achieve that the respondents’ responses are scientifically usable, unambiguous and clear, there were several workshops, in which questionnaire’s questions were discussed and improved. The questions are linked with electronic data system. It is planned both to enter the respondents’ data in digital on-line format and to keep the original paper files. Both hard copy and digital data systems are linked together.
3. Surveyor’s Handbook is ready. It includes explanations of terms and abbreviations used in the questionnaire, as well as description of study’s goal, tasks and methods, respondent selection criteria, requirements for the interviewer, interview place and technologies, description of survey process and explanation of each question; also, survey quality ensuring. The Handbook includes contact details of responsible researchers from University of Latvia, as well as several appendixes regarding survey process. The Handbook will be a training tool for surveyors during the study in order to ensure precise data gathering. The Handbook will be prepared in Latvia and it’s going to be translated to Russian.
4. GISTAR Information Leaflet and Informed Consent Form is ready. According to international guidelines and good clinical practice requirements, the plan is for every potential study participant to read information on the study (GISTAR Information Leaflet), and if he agrees to study conditions, he signs the Informed Consent Form, which signifies participant’s willingness to participate in the study. The Leaflet and Consent Forms are in English (8 pages altogether). These documents are going to be translated to state language of the country, in which it will take place.
5. In order to implement the study according to screening guidelines, information on high morbidity criteria and ESF Project’s screening results, GISTAR inclusion/exclusion criteria were developed. These criteria were discussed in ESF Project researcher workshop on national and international levels (in cooperation with research centres in Russia and Belorussia, as well as with IARC). IARC confirmed the criteria. The criteria, as well as the study protocol, are in English.
6. In order to ensure quality of study results and efficacy of screening, it is necessary to define the further processes according to screening guidelines and quality criteria. The adequacy of these guidelines and criteria to Latvia’s conditions was tested during the screening studies. Based on study results, standard operating procedures (SOPs) were developed for GISTAR study. The authors of these SOPs, including endoscopy procedure, are ESF Project researchers.
7. In order to ensure complete study data confidentiality and to get international approval of the study protocols, it is necessary to develop data system safety and usage instructions. The instructions for safe use of the data system were written by ESF Project researchers and data safety specialists from the University of Latvia. The instructions cover the responsible persons, user rights and responsibilities, system password structure and system usage, backup copy creation, physical and logical protection of data.
8. In order to ensure sustainability of the Project results and to popularise GISTAR study, a number of events were organised, including International Conference (March 22-23, 2012) on ESF Project’s Screening Results and Study Expansion Project Protocol. Within the scope of these events information materials on GISTAR study were prepared in Latvian, Russian and English languages.
9. We have gathered and systematised information on potential international partners in screening study results, including research centres in regions with high prevalence of oncological diseases – Russia and Belorussia.
Note. Additional information on specific matters regarding the study and limited access information, including study protocols and other related documents, are available by contacting e-mail: firstname.lastname@example.org or calling by phone +371 25153015.