Information to research participants

Cancer is one of the most common and severe diseases. Early detection of cancer improves treatment outcomes, as tumors detected at an early stage have had less time to grow and spread. While screening tests contribute to early detection for some types of tumors, better tests are needed to enable screening programs for additional cancer types.

The purpose of the PRIC study is to investigate new methods for detecting existing cancer or assessing an individual´s future risk of developing cancer. The aim is to develop new tests based on blood samples and self-reported health and lifestyle information. Adults living in Sweden are invited to participate in the study, and we therefore ask you if you want to be one of the participants. We obtained information about your age and address from the Swedish Population register at the Swedish Tax Agency.

The research principal responsible for the study is Uppsala University. The Swedish Ethical Review Authority has granted an ethical permit for the research in the study, the permit reference number is 2024-08607-1.

After registration, you will complete a digital questionnaire on your health and lifestyle, which takes approximately 5-10 minutes. Shortly after you will receive a letter containing material and instructions for collecting a small sample of blood from your fingertip. We ask you to place 1-4 drops of blood on a paper card included in the sampling kit and return it using an envelope with pre-paid postage provided by the study.

We will analyze your blood sample, along with those from many other participants, by measuring the levels of various molecules. We will investigate if these measurements, along with questionnaire responses, can be linked to a participant’s likelihood of receiving a cancer diagnosis within a specific timeframe. To assess test accuracy, we will compare cancer risk with the risk of developing other common diseases. If a participant is diagnosed with cancer during the study follow-up, we will also examine potential associations between test results and disease progression.

You will be invited to repeat the blood sampling in the same manner once per year for three years. This enables us to track changes in your blood measurements over time. On each occasion, you are given the choice to submit another sample or not. Even if you later decide to discontinue participation, any previous samples you provided will remain valuable for research.

The study will collect and process your personal data, including your questionnaire responses on health and lifestyle, results from blood sample analysis, and information from registers maintained by the Swedish Tax Agency and the National Board of Social Affairs and Health. The information collected from the registers includes basic personal information, and information on cancer risk factors, and past, present and future diagnoses of cancer and other diseases. We will use the health care national quality registers and your medical records to retrieve information needed for the analyses.

Your personal information will be safeguarded from unauthorized access. The project will use secure systems at Uppsala University for information storage, with access restricted to a few persons. The study will use artificial unique study ID numbers for each person when data are analysed, so that no information can be linked directly to you without access to a code key. The key is stored in a separate location from the study register at Uppsala University. Your personal information will be stored during the full course of the study, which is 15-20 years, and then managed in accordance with Swedish legislation. Published study results will not contain any information that could identify you or other participants.

The purpose for processing your personal data is research and the legal basis for the processing is that the handling is necessary for the performance of a task carried out in the public interest. Uppsala University is the data controller for your personal information. Under the EU General Data Protection Regulation (GDPR), you have the right to obtain a copy of your personal data in the study register free of charge, and to have potential errors corrected. You may also request deletion of your data or restriction of its processing, subject to certain limitations related to the research. To request a personal data extract, contact the study team at pric-studien@uu.se. The Uppsala University Data Protection Officer can be reached at dataskyddsombud@uu.se. If you have concerns about data processing, you may contact the Swedish Authority for Privacy Protection.

The procedure involves a finger prick, which may cause a brief stinging sensation, but any discomfort should resolve quickly. The sampling kit includes a disinfectant wipe to clean your finger before sampling and a plaster to cover the puncture site.

The project results will support research on development of new methods to detect cancer, but will not influence your own current healthcare. You should continue to participate in standard cancer screening programs as recommended by your healthcare provider.

Your blood samples will be stored in Uppsala Biobank (IVO 827) with the two principals Region Uppsala and Uppsala University. From the sample cards, we will take several small specimens for different types of analyses over time. Analyses will be conducted in laboratories in Sweden or, if necessary, in other EU/EES countries or third countries. Your samples will be labeled with a unique code, which cannot be linked to you without access to the separately stored code key.

You have the right to at any time, without explanation, decline the storage of your samples. If you consent to your samples being stored, you may later withdraw your consent without explanation. Your samples will then be discarded. To withdraw your consent, contact the study principal investigator at pric-studien@uu.se. Your samples will be used only for this study, as per your consent. However, they could be valuable for use also in other studies. If you agree to allow use of your samples also in future research, you must provide explicit additional consent also to this. For any new project that wants to use your samples, the Ethical Review Authority will decide during their review of that project if you should be contacted to provide new consent to the new study.

The research findings will be published in scientific journals, presented in such a way that it is not possible to identify individual research participants. As this study focuses on developing new diagnostic tools, individual results will generally not be shared with participants. However, general study updates and findings will be available on the project website, and may be reported in media, social media, and scientific or public lectures.

If the research uncovers information with potential implications for your future health, you may opt to be contacted about such findings. A medical advisory group will determine if you should be offered contact, and you will be able to decide whether to receive the information or not by confirming your choice using BankID. Only findings with actionable medical follow-up or intervention will be communicated.

The research may lead to future follow-up studies on disease prevention, risk reduction, or optimal treatment strategies. You may opt to be contacted for potential participation in such future studies.

You will not receive any financial compensation for participating in the study. We refer to your health insurance for the sample collection carried out by you in your home. The study provides all necessary materials for sampling and covers the costs of the sampling kit, postage, and return envelope.

Participation in the study is voluntary. You may at any time withdraw from the study without providing a reason. Withdrawing will not affect your healthcare or treatment. To withdraw, contact the principal investigator of the study (see below).

The study is led by Professor Tobias Sjöblom at Uppsala University, Department of Immunology, Genetics and Pathology.

For inquiries, contact the principal investigator and study team at pric-studien@uu.se or by phone, 018-471 41 03.