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CLINICAL STUDY PARTICIPANT INFORMATION SHEET
Molecular Pathogenesis of Blood Diseases, Risk Factors, and Personalized Care Dear Study Participant
You are invited to participate in a study for development of methods aimed at improvement of blood disease treatment. This Information Sheet describes the study and your participation.
Background of Study Comprehensive knowledge of the causal mechanisms (pathogenesis) of certain blood diseases has created the possibility for development of targeted therapies. In particular, in case of chronic myeloid leukaemia, the prognosis and treatment have improved considerably with the development of targeted care.
Cancers of the blood have complicated aetiology; so far, there has been no comparable success in determination of the causal mechanisms and treatment of the disease. As regards current therapies, leukaemia that tend to recur or are unresponsive to treatment constitute a special challenge.
In recent years, there have been considerable developments in case of various research methods, especially in mapping of the cancer genome, which has made possible identification of individual treatment targets in an entirely new way. Precise understanding of the pathogenesis of leukaemia is the key to development of targeted and personalized treatments.
Purpose of Study This study aims to map the possible anomalies of your diseased cells and healthy cells as comprehensively as possible, using state-­‐of-­‐the-­‐art research technologies in co-­‐operation with the Institute for Molecular Medicine Finland (www.fimm.fi). Our objective is to find new methods for blood disease diagnostics, monitoring, and treatment.
Implementation of Study Blood disease patients participate in the study. Blood, bone marrow, lymph node, skin, and cerebrospinal fluid samples are used. In general, all samples are collected in connection with regular, treatment-­‐related samplings. The average additional sample volume amounts to 5-­‐50 ml of bone marrow and/or blood. Bone marrow samples are collected in compliance with normal practice, under local anaesthesia, using other pain medication as required. A small number of eligible patients will be requested to provide bone marrow samples from three different sites (hipbones, sternum), for the purposes of evaluating the extent of disease characteristics variation depending on the anatomical location.
For you, there will be no study-­‐related additional expenses, and monitoring of the disease will take place in accordance with the regular treatment procedure. In addition to the study samples, we request permission to examine your medical record and the results of any laboratory samples taken from you.
Besides this, we request permission to examine possible samples collected earlier, during the disease diagnosis and monitoring stages.
Diseased cells collected from you will be studied by different methods for precise determination of their characteristics (for example, drug sensitivity testing, diseased cell and healthy cell genome mapping). If therapeutic targets are found, this information can be utilised in situations where standard therapy is not available (for example, leukaemia that are recurring or unresponsive to traditional treatment).
If possible, genetic blood disease risk factors are also determined based on the samples taken. The goal is to establish the genes relevant to cancerous blood disease occurrence and the basis of their effect. Besides 1
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inherited susceptibility, we study the changes taking place in diseased cells during their development in order to understand the emergence and progression of the disease. We hope that the information acquired will promote blood disease diagnostics, prevention, and treatment. It is also possible that other than blood disease-­‐related important information is discovered by chance in the course of the study.
Diseased cells collected from some of the patients may be cultivated under laboratory conditions for a long time (several months/years), so that they can be used for examination of the basic disease mechanisms. Long-­‐term growth of cells in such cultures may also be promoted by modification of the cell genome or other growth-­‐promoting measures. Such established cell lines may also be made available to other researchers engaged in the same field for non-­‐commercial research purposes. Even though the identity of patients who donate their cells for creation of such cell lines will be kept secret, there is a possibility that the cell line and the related genome changes can be traced back to the study participant or their relatives in the future, for example, by comparing databases.
Some of the participants will undergo positron emission tomography (PET). It will be combined with low-­‐dose computed tomography (CT) or magnetic resonance imaging (MRI). The procedure utilises the annihilation radiation resulting from decay of radioactive isotopes. The PET-­‐MRI scans will be carried out at the PET centre in Turku.
Participation in the study is voluntary and refusal to participate will not affect the rest of your treatment in any way. You can also terminate your participation at any stage without giving any reason.
Possible Benefits and Disadvantages of Study Most likely, you will not directly benefit from the study. However, the study could help to improve the treatment of other blood disease patients.
The study will cause you minor inconvenience because of the time required for additional sampling. No special sampling sessions are required within the framework of the study, but the volume of extra samples to be collected entails a minor risk comparable in case of both blood and bone marrow samples to the risks associated with routine laboratory sampling. Skin biopsy may cause some pain regardless of anaesthesia. Skin biopsy is also associated with a low risk of infection and may leave a permanent scar at the biopsy site. Insurance coverage is ensured by the hospital’s patient insurance.
PET-­‐CT or PET-­‐MRI exposes the subject to radiation. The effective radiation dose under the study is about 7-­‐10 millisievert. Among the population of Finland, the average annual radiation dosage is 3.7 millisievert (Source: STUK). Radiation may predispose cells to genetic changes and cancer. The risk, however, is small. People of fertile age will not be included under the study.
Because of the study, your medical record data may become accessible to a larger number of people than necessary from the viewpoint of your treatment (for additional information, see Confidentiality and Protection of Data).
Confidentiality and Protection of Data All of your information will be treated in a confidential manner. Any samples taken from you will be coded to avoid identification of your personal data based on study-­‐related research, reports, or publications. The data will be stored and deleted after the end of the study in accordance with the related instructions. If you wish, you can have access to any study results that concern you. Representatives of the Finnish Medicines Agency (the authority responsible for pharmacovigilance and safety) have the right of verifying the accuracy of study results and appropriate conduct of the study.
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Reporting of Study Results It is also possible that other than blood disease-­‐related important information is discovered by chance in the course of the study. A possible example is the genetic changes that strongly affect the blood cholesterol level. If any such changes are discovered, you will be informed of the results if you wish so.
Additional Information If you have any questions about the study, you may contact the medical researchers or your attending physician. You can discuss any study-related matters with them.
On behalf of the research group,
Mika Kontro
Medical Specialist,
Study Investigator, tel. 050-­‐4287052 Kimmo Porkka
Professor, Chief Physician
tel.: 09-­‐471 71890 Hematology Clinic, Helsinki University Central Hospital, and Hematology Research Unit, Biomedicum Helsinki, PL 700, 00029 HYKS
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Molecular Pathogenesis of Blood Diseases, Risk Factors, and Personalized Care CONSENT
I have received detailed oral and written explanation on the aforementioned study and hereby voluntarily agree to take part in it. I am aware of that I can discontinue participation in the study at any stage of the study before its completion without any negative consequences for me. I can also revoke this consent, in which case my information and samples collected will no longer be used for research purposes.
I hereby give permission to collect information from my medical record entries and other laboratory tests. I also give permission to conduct further research on my earlier samples.
□ Yes О No I understand that although my entire genome could be used within the framework of the study, instead of comprehensive interpretation of my genetic information, the study is focused on the genes of diseased cells. The study could identify changes relevant to my own state of health that can potentially be influenced by preventive intervention.
In such cases (please tick the right box):
□
Please contact me only in tumour risk-­‐related matters.
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Please contact me in case of any findings of utmost importance from the viewpoint of my state of health and in which case preventive intervention would be possible. I understand that many people are carriers of some autosomal recessive disorders and identification of such a carrier status is not a reason for contact.
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I do not wish to be contacted; I provide samples only in order to promote scientific research.
I hereby give permission to create cell lines for research application from my diseased cells.
□ Yes Date
О No Signature
Transcription of the name
Personal identification number
Address:
Oral explanation provided by:
__________
Signature
Transcription of the name 4