DEDUCER

Information about the processing of personal data in the deducer study (PDF, 189 KB)

On this page you will find the Deducer study consent form. Deducer is a biobank research project of the Urology Clinic of the HUS Helsinki University Hospital. This study examines the use of new of methods in the diagnostics and treatment of urological cancers. For example, the study might uncover genetic changes in cancer cells and the individual response of the patient’s tumour cancer cells to various cancer medicines. We are recruiting patients coming to the urology clinic for examinations or treatment, regardless of whether they are suspected of having cancer. Participation in the study does not affect any diagnostic examinations made at the urology clinic or the treatment you receive. Study samples are taken at the same time as diagnostic samples to make participation as easy as possible. You can find more information here.

Development of Diagnostics and Treatment of Urological Cancers (DEDUCER)

We invite you to participate in a study that examines the use of methods in the diagnostics and treatment of urological cancer that have previously been used only in research context. For example, the study might uncover genetic changes in cancer cells and the individual response of the patient’s tumour cancer cells to various cancer medicines. We have assessed that you would be suitable for the study because you are suspected to have or have been diagnosed with urological cancer (e.g. prostate cancer, urinary tract cancer, kidney cancer, testicular cancer or penile cancer).

This information leaflet describes the study and your possible part in it. Please take your time to read through this leaflet. If you have any questions, please contact the person responsible for the study or other research personnel; you can find their contact details at the end of this document. If you decide to participate in the study, you will be asked to sign a separate consent form either in writing or electronically.

The Research Ethics Committee of the Hospital District of Helsinki and Uusimaa (HUS) has reviewed the research plan of this study and given a favourable opinion for the study.

Participation in this study is voluntary. At any stage, you may refuse to participate in this study, terminate your participation or withdraw your given consent without giving a reason and without this affecting your right to receive the treatment you need and without your refusal resulting in any other negative consequences for you. You do not have to participate in this study in order to receive treatment.

If you wish to cancel your participation in the study, please contact: Antti Rannikko, 050-4270041, antti.rannikko@hus.fi.

If you withdraw your consent, the data and/or samples that were collected by the date of withdrawal will be used as part of the research material. This is necessary to ensure the safety of the research results and people participating in the study.

Treatments for urological cancers have improved dramatically in recent decades. However, some urological cancers do not yet have effective treatment. It is sometimes challenging to do early-stage diagnostics and to predict how the disease is going to develop in the case of an individual patient. For example, the majority of prostate cancers are clinically irrelevant, which means that they do not need to be treated at all. However, some of these cancers require more effective treatment than what is currently given. The aim is to find more effective pharmacotherapies for some urological cancers or to assess the cancer patient’s response to new promising medicines (e.g. immunomodulators). The assessment of prognoses and treatments for urological cancers can only develop through basic and clinical research. In recent years, significant additional information on the birth of cancers has been obtained when mapping the genome of benign and malignant cells in humans. Our goal is to improve the diagnosis and treatment of cancer through the use of new research methods, which would allow an increasing number of patients to receive more efficient individually tailored precision treatment.

The aim of this study is to apply new methods that are already routinely used in research activities to the diagnosis and treatment of cancer. Samples are collected from patients who have given their consent without compromising standard diagnostics e.g. urine, blood, and tissue sampling at different stages of the disease where applicable. The collected samples will be subjected to the studies described below to further determine the nature of the potential cancer. The samples and their data are stored and data from patient documents and other registers are attached to them. The goal is to develop new methods for the diagnostics, treatment and prognosis of urological cancers and to improve the prognosis of patients with these diseases.

We are asking for consent from patients in the Helsinki University Hospital specific catchment area (HUS, South Karelia, Kymenlaakso and Päijät-Häme health care districts) who are suspected to have or have been diagnosed with urological cancer and who are sent for further examination or treatment or who are already in treatment or under monitoring. In the diagnosis phase, during possible treatments and/or during cancer monitoring, some of the following are collected from patients who have given their consent, as appropriate:

Urine, blood, and tissue samples

Ascites and/or pleural fluid sample

Microbiological saliva and/or faecal samples

The total volume of blood samples shall not exceed 100 ml of blood (vein blood sample) per sampling. Tissue samples include tissue removed during cancer surgery or taken during biopsy without compromising primary diagnostics. Examples of key research methods are:

1. Storing the samples mentioned above in the sample storage unit for future studies.

2. Isolation of (cancer) cells in the sample (tumour or normal tissue), cell and tissue culture, and determining drug susceptibility.

3. Further culturing of cultured cells as “permanent” cell and/or tissue models for the study.

4. Determining the alkaline order of the whole genome or all genes in the sample (so-called thorough sequencing and bioinformative identification) and other identification of the molecular profile of the sample as well as clinical chemistry analyses.

5. Corresponding analyses of the patient’s normal tissue (e.g. tissue sample, blood sample) for reference and examination use.

6. Analysis of a previously taken (e.g. during the diagnosis phase) and archived cell or tissue sample taken from the patient or analysis of cell or tissue samples taken during treatments and monitoring.

7. Analysis of clinical imaging (e.g. MRI, computer images, isotope imaging), analysis of cell and tissue samples and their digital recordings and clinical data (patient record systems, patient register and national registers (Cancer Register, THL registers, Statistics Finland registers, Findata, Digital and Population Data Services Agency) together with other data, using traditional statistical analysis or using deep learning and artificial intelligence.

In other words, the aim is to examine the samples you give and determine, within the limits of available resources and using all available techniques, whether there is a change in your cancer that would contribute to the development of diagnostics, prediction of cancer behaviour and/or therapeutic action. Based on the results of the sequencing and drug susceptibility analysis, it is possible, for example, to make the necessary additional determinations of the blood and/or urine sample taken if, for example, there is a measurable marker for the changed signal route in question.

Samples are collected in HUS units and processed in HUS laboratories or hospitals and in the facilities of the University of Helsinki. Samples are stored at HUS and/or the University of Helsinki in a modern and reliable sample storage unit. The storage of samples is carried out by trained personnel.

The molecular diagnostic examinations of the samples are carried out at HUS or the University of Helsinki, in cooperation with other research groups or by companies offering analytics as outsourced services.

A representative of the research group may contact you to ask for additional information and about taking further samples during or after the study. You may also be contacted concerning, for example, the prevalence of certain diseases in your family. If we ask a relative of yours to participate in the study, they will be asked for their consent separately.

The total estimated duration of the study is five years.

The results of the study and your (encoded) personal data included in the research data will be stored in compliance with legislation for 25 years from the publication of the results of the study in accordance with the principles of good clinical practice, after which the data will be destroyed. If any samples used in the study remain, they will be destroyed no later than 25 years after the end of the study. The aforementioned does not apply to research material that has been stored in a biobank subject to separate consent. You can read more about the storage of biobanked research material in a separate biobanking information leaflet and consent form.

This study is carried out by HUS (Urology Clinic) and the University of Helsinki, and they also act as joint controllers of the personal data processed in the study. The study is carried out on the premises of the above-mentioned organisations. The person responsible for the study is Antti Rannikko (contact details can be found at the end of this information leaflet).

The research group is responsible for the research funds. The research is funded by i.a. HUS (State Research Funding), Jane and Aatos Erkko Foundation, Academy of Finland, and Cancer Society of Finland. No compensation will be paid to the Research Centre for carrying out the study. Research physicians and other personnel are not paid any separate compensation for carrying out the study.

It is possible that you will not benefit from participating in this study. However, the information produced by the study may help to determine whether there are new diagnostic or predictive methods or possible new treatments for the cancer being studied. We may also obtain useful information on the studied disease.

You may be informed of any so-called incidental findings made in the study if you separately consent to that.

The study will cause you a minor inconvenience caused by the time it takes to collect samples. There is a minor risk associated with the number of samples to be collected, which is comparable to the risk associated with the sampling of a routine laboratory test and, in the case of biopsy, to the risk associated with normal biopsy. Collecting a sample of a tumour removed during a possible cancer surgery does not cause you any additional inconvenience or risk. The person responsible for the study can tell you about other possible harms.

HUS has insured the participants in the study under the Patient Insurance Act. If the studied device or a procedure performed as part of the study causes personal injury to you, you can seek compensation from HUS’s patient insurance.

You will not be paid a fee or compensation for participating in the study.

This study is subject to Finnish and European legislation on the protection of research and personal data, the most important of which are:

Medical Research Act (488/1999)

EU General Data Protection Regulation (2016/679) and the Finnish Data Protection Act (1050/2018)

Act on the Status and Rights of Patients (785/1992)

Act on the Medical Use of Human Organs, Tissues and Cells (101/ 2001)

Researchers and other research personnel are pledged to follow good scientific practice and the ethical guidelines associated with research. In the study, your identity is only known by the research personnel, all of whom are bound by the confidentiality obligation.

The primary basis for processing personal data in this study is scientific research based on the public interest.. Samples, data, and research results collected about you will be processed in a manner required by law.

All data collected about you during the study are processed in an encoded format so that you cannot be identified directly from the research results, reports or publications related to this study. Encoding means that your name, personal identity code and other directly identifiable information will be deleted and replaced with a unique code. After this, all data collected about you cannot be identified without the code key, which it is the responsibility of the person in charge of the study to store. Parties outside the research group do not have access to the code key, which is stored separately from the research material in a secure space. The research results are analysed in encoded form. You will only be referred to by a code number in the research results and other documents. The encoded material is handled confidentially. The processing of your directly identifiable personal data (e.g. name, personal identity code) is limited to the minimum, such as to any communication or withdrawal of consent.

A large part of your data processed in the study consists of the data analysed from the sample you provided and described in the section “Study measures and methods” above.

To ensure the accuracy of the research data, the research data is compared to, among other things, the original patient record data and register data concerning your state of health that is necessary for the study, which are processed under the supervision and responsibility of the person responsible for the study or other research personnel. In such a case, members of the research personnel may use your personal identity code to obtain the information needed. We will use the data concerned to the extent required for the implementation of the study. In the study, your data will be collected from the following registers:

• Health care unit’s patient registers

• Other registers containing health-related information (Cancer Registry, The Finnish Institute for Health and Welfare (THL), KELA, Statistics Finland, Digital and Population Data Services Agency).

Data collected from the registers include: demographic data (underlying diseases, medications, treatments), results of diagnostic examinations (clinical studies, imaging, laboratory tests, tissue samples), surgical/radiation/pharmaceutical treatments, drug reimbursement register data, reimbursement register data (medicine reimbursements, medical expense reimbursements), death certificate data

For more information on the processing of your personal data and the related rights, see the most up-to-date privacy notice for the study available on our website: www.hucc.fi/ongoingtrials/deducer.

The research team may share the personal data collected for the study, the personal data created in the study and other personal data used in the study, the patient document information used in the study as well as the samples collected from you and the cell and tissue models derived from them (together referred to as the "research material”) with parties outside the research team in situations described below. Research material is always disclosed in an encoded format and the recipient will never know your identity (with the exception of the below data disclosure to a biobank, in which the data are encoded separately).

Disclosure situations:

1. The research material (incl. encoded patient document information) can be used and disclosed in an anonymised form to national and international research cooperation with non-profit research institutes and other public bodies (universities, hospitals, national and international organizations, authorities, etc.) and with national and international companies. The research material is used only for research cooperation aimed at developing medical diagnostics, treatment or monitoring. Research cooperation is always agreed on in writing, including the obligation to keep the research material secret. As part of research cooperation, the research material may be combined with other research material to form a larger data set.

2. The research material may be used in an encoded form in similar studies in the future. The precondition for this is that the other study has been granted a favourable statement by the Ethics Committee and the activities and data processing taking place in it are compatible with this study.

3. The information obtained from the samples in the research material and the data related to them can be stored in supervised databases in an encoded format. This makes the widest possible use of the results of the study possible in order to promote science and is often a prerequisite for drawing up scientific publications. An example of such a database is the European Genome-Phenome Archive (EGA, https://ega-archive.org/). Requests for information will be evaluated by the personnel of this study before the disclosure of the research material and the disclosure of the research material will be agreed upon separately. Data are disclosed from the database only to research projects promoting the public interest, aimed at developing medical diagnostics, treatment, and monitoring. There is a small possibility that the data published by comparing different databases could be connected to the subject or their relatives.

4. If you give or have given a separate biobank consent, samples that are part of the research material and the data related to them can be stored in the biobank during the study or after the study has ended. The biobank may disclose these samples and the data related to them to other biobank studies. You will find more information in the separate biobank consent.

Research material may also be processed by national and international supervisory authorities and other parties that have the right to carry out inspections under the law or an agreement. Quality control monitoring can be carried out in the study, in which an external evaluator who is bound by professional secrecy can view individual data.

Disclosures of research material and the related protection of personal data are always agreed upon separately. The data controller(s) is/are responsible for these measures. For more information on the above-mentioned partners and the disclosure of research data and the processors of personal data used in the study, please see our most up-to-date privacy notice: www.hucc.fi/ongoingtrials/deducer/partners

You cannot be directly identified from the scientific publications related to the study. We always aim to ensure that the data in the publication have been anonymised to the extent it is possible.

In addition to the usual scientific publications, it may be necessary to draw up scientific publications based on case-studies on the findings made in the study. These publications concern the findings made in only one or in a few study subjects. We will draw up such publications only if it is well justified from the scientific point of view. Your data contained in such a publication is always encoded and thus the publication never discloses any information that directly reveals your identity. However, it should be noted that even encoded information in the case study publication may be unique to you.

If you have any questions about this study, you may contact the person responsible for the study or other research personnel. With them, you can discuss all issues related to the study.

Electronic signing

After clicking the "sign" button, you are directed to electronic signing of the research consent