Clinical trial: NCT02878434
Section: Confidentiality
Subsections: Confidentiality And Data Protection

The information that will be obtained about you will be handled with complete discretion and will only be used for this study. Your treating doctor is responsible for the protection of the data. In order to protect your identity, your personal information and other data that are obtained from the study will be identified by means of a unique number. Your name will not be mentioned in publications or reports of this study. If you want to discontinue your participation in this study, no additional data will be collected. The information that has been collected until then, however, will be used for analysis. Under strict conditions, direct access to the medical file can be granted to authorised personnel of the principal (UZ Leuven via prof. F. Amant) or of his representative(s), to regulatory authorities or to other persons who are authorised by law to check if the research is being carried out correctly.  
Access is only granted to examine the quality of the collected data, so it will not be granted systematically. Direct access to the medical file by third parties will exclusively be granted in the presence and under responsibility of the supervising researcher or fellow researchers.  
Study number: S 59981 02-10-2018, Version 1.3 Everyone who has access to the medical file is bound to the professional secrecy.  
  
The participant always has the right to ask the researcher about the data that are being collected for the study as well as the purpose of this data. She also has the right to get insight in her personal information through the researcher and, if needed, to make alterations. All personal information and other data will be treated and processed in accordance with EU regulation 2016/679 and the Belgian legislation on the protection of natural persons with regard to the processing of personal data.  
If you have further questions about data protection, please do not hesitate to contact the Data Protection Officer of UZ Leuven: gdpr.research@uzleuven.be. You have the right to lodge a complaint about how your information is treated with the Belgian supervisory authority responsible for enforcing data protection legislation: Data Protection Authority
(DPA), Rue de la Presse 35, 1000 Brussels, +32 2 274 48 00, contact@apd-gba.be, www.dataprotectionauthority.be
Clinical trial: NCT02878434
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Advantages And Disadvantages Of Your Participation In This Study

Taking part in this study will not lead to personal advantages but it can help to obtain useful scientific information for the future. There are no disadvantages, risks or discomfort expected when participating in a registration study.
Clinical trial: NCT02878434
Section: Procedures
Subsections: Description Of The Study

Within the framework of this study, we will as precisely as possible record your medical data with respect to the diagnosis, the treatment and the outcome on the basis of your medical file. If applicable we will register your following pregnancy(ies) and the general condition of your child. In order to do so, we would like to ask your permission to reclaim information about your medical file from your family doctor.  
You do not need to undergo any extra procedures for this study.
Clinical trial: NCT02878434
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

Fertility sparing cancer treatments are treatments that deviate from the standard treatment in the sense that the alterations are focused on preservation of fertility. An example can be an operation for cervical cancer with removal of only the cervix instead of the entire uterus or removal of a part of the ovary in ovarian cancer or freezing oocytes or embryos before starting cancer treatment. Since fertility sparing cancer treatments are not so frequently performed, there is insufficient knowledge about the treatment and outcome of women who undergo such treatment. The purpose of this study is to map out the issues regarding fertility preservation during and after the cancer treatment. By registering both women who undergo fertility sparing cancer treatments and women who undergo the standard treatment, we can investigate and compare the outcome of both. Together with this we want to investigate if women who undergo fertility sparing cancer treatments, experience more problems getting pregnant and during pregnancy. This way we can obtain a better insight in these problems and the outcome of these women.  
Study number: S 59981 02-10-2018, Version 1.3
Clinical trial: NCT02878434
Section: Voluntary Participation
Subsections: Your Participation Is Voluntary

It is up to you to decide if you want to participate or not in the study. If you give your consent for participation, you will be asked to sign the attached consent form. You can revise your decision at any moment without any specific reason. If you decide to not take part or to discontinue your participation, this will not have any influence on the quality of your current or future medical care and you will not lose any benefits you are normally entitled to.