Clinical trial: NCT04005183
Section: Alternatives
Subsections: Alternatives To Being In The Study

You do not have to join this study to receive treatment for your condition. If you decline to join this study your treatment will not be impacted and you will still receive the current standard of care at UHN, which is nephrectomy.
Clinical trial: NCT04005183
Section: Participant's Rights
Subsections: Rights As A Participant

By signing this form you do not give up any of your legal rights against the investigators, or involved institutions for compensation, nor does this form relieve the investigators, or involved institutions of their legal and professional responsibilities.
Clinical trial: NCT04005183
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risk

A *biopsy sample* from your surgically removed kidney tumor will be taken after nephrectomy. There are no additional risks associated with this biopsy as it is taken after your surgery. Renal tumor biopsy - There is a small risk of bleeding from the additional tumor sample that would be taken for research purposes from your kidney tumor. There is also a risk of tumour cells escaping along the pathway of the needle tract. This is not specific to the additional research sample taken, but a generalized risk of biopsing the tumor. This risk is estimated to be rare as there have only been 5 cases reported in the scientific literature.  
Blood and urine collection - There are no risks associated with blood or urine collection as these will be obtained during your operation from blood and urine samples being taken as part of your routine surgical care. While all health information collected for the purposes of this research will be kept confidential and secure, there is always the risk of accidental disclosure. Risks of Genetic Testing - When you donate your blood or tissue for genetic testing for research, 3 of 8 you are sharing genetic information, not only about yourself, but potentially also about biological (blood) relatives who share your genes or DNA. The probability of identifying such heritable genetic changes is unlikely, but should be considered. There is a risk that information gained from genetic research could eventually be linked to you. This potential re-identification of the information (e.g., to an employer or insurer) may lead to loss of privacy and to possible future discrimination in employment or insurance against you or your biological relatives. However, the only identifying information that will be present on the sample is your study number, and only the Study's Doctor and study team would have access to your medical records.
Clinical trial: NCT04005183
Section: Voluntary Participation
Subsections: Consent Form To Participate In A|Voluntary Participation:

Research Study  
cores for research purposes is optional. You will be given options (if applicable) at the end of this consent form. We will also collect a urine (30-50ml) and blood (10-20ml) sample from you during your operation. These samples will be processed for genetic analysis along with your tumor in order to provide a normal comparison and help the research team identify mutations/adverse changes present in the tumor tissue. Note, in order to participate in this study, you must agree to collection of tumor, blood and urine samples. These are not optional for participation in this study. All samples (including blood, urine, tumor) will be sent to a research laboratory at the University of Toronto and processed for genetic analysis. The samples will also be grown in the University of Toronto lab on a plate as well as implanted onto mice to determine reasons why or why not they respond (i.e shrink) when treated with various therapeutic agents.  
Additionally, a portion of these samples (including blood, urine, tumor) will be frozen immediately and stored in a vial labeled with a unique study number; no identifying information will be placed on the vial. These samples will be processed at a later time for whole genome sequencing as part of this study, which will take place at a genomic sequencing facility at the University of Toronto. Note, these samples will be stored in Ailles Lab in the Princess Margret Cancer Research Tower during analysis and then moved to the UHN Biobank. They may later be used for additional analysis for this research study and/or future research purposes. After removal of samples from your tumor for research, the remaining tumor tissue will be securely transported to Mount Sinai Hospital for MRI imaging. Following this it will be transported back to Toronto General Hospital for standard pathology assessment. De-identified clinical information (e.g. your age, gender, disease history, diagnoses, radiological imaging scans, treatment courses) relevant to kidney cancer will be collected for research purposes to better understand the disease. Please refer to Confidentiality for further details.

Your participation in this study is voluntary. You may decide not to be in this study, or to be in the study now, and then change your mind later. You may leave the study at any time. We will give you new information that is learned during the study that might affect your decision to stay in the study. If you are a First Nations or an indigenous person who has contact with spiritual 'Elders', you may want to talk to them before you make a decision about this research study. Elders may have concerns about some genetic procedures.
Clinical trial: NCT04005183
Section: Withdrawal from Study
Subsections: Withdrawal From The Study:

If you decide to leave the study, you have the right to request withdrawal of information collected about you. Let your study doctor know. If you decide to leave the study, you have the right to request withdrawal of your biopsy tissue, blood and urine samples and information obtained from these samples. Let your study doctor know. If you decide to leave the study, you have the right to request withdrawal of your radiological images and information obtained from these images. Let your study doctor know.