Clinical trial: NCT03294122
Section: Confidentiality
Subsections: Will My Taking Part In The Study Be Kept Confidential?|Holder Of The Treatment Of Your Personal Data And Related Goals|Nature Of Data|Data Processing Procedure

All information will be kept strictly confidential and your name will not appear on any publications resulting from the study. Your medical notes will be seen by authorised members of the research team at this institute, so that they can collect information needed for the MICRO-LEARNER study. You will be given a unique MICRO-LEARNER study number, which will be used together with your initials and date of birth on any forms that the research staff fill in. Samples will be coded with the unique MICRO-LEARNER study number and kept anonymously which means that the laboratory researchers who are carrying out any tests on your sample cannot identify you. All information about you will be treated as strictly confidential and nothing that might identify you will be revealed to any third party.

Fondazione IRCCS Istituto Nazionale dei Tumori will treat your personal data, especially those related to your health, and only to the extent that they are essential in relation to the purpose of the study, exclusively for the purpose of fulfillment of the study.  
The up-to-date list of data managers for the patients participating in the study and of all subjects that treat your data - including laboratories for analysis - are available and on your request the clinician who is taking care of you will be able to provide it.

The doctor who will undertake the study will identified you with a code: the data relating to you collected during the study, except your name, will be recorded, processed and stored together with this code and with your date of birth, gender, weight and height. Only your doctor and any authorized parties can connect this code to your name.

Your data, also processed by electronic means, will be distributed only in in strictly anonymous form, e.g. through scientific reports, statistics and scientific meetings.  
The data, also processed using electronic instruments, will be released only in anonymous form, such as through scientific publications, statistical reports and presentations at scientific conferences.  
Your participation to the study, in agreement with regulation on clinical trials involving drugs, entails that any persons employed for monitoring and verification, the Ethics Committee and any regulatory authorities (from Italy or from foreign country) will have direct access to data and medical records to verify the study procedures and / or data, in such a way as to guarantee the confidentiality of your identity.
Clinical trial: NCT03294122
Section: Participant's Rights
Subsections: Exercise Of Rights

Under Article 7 of Italian Legislative Decree no. 196/2003 (the so-called "Code of privacy"), you are entailed to exercise your right (such as access your personal data, integrate, correct them, oppose to their processing for legitimate reasons) addressing directly to the experimental center (Prof. Valdagni, Radiation Oncology 1, 02 23903034).  
You may terminate at any time, without giving any reason, your participation in the study: in this case, the biological samples relating to you will be destroyed. Additionally, no further data relating to you will be collected, subject to the use of those data already collected to determine, without altering them, the results of the research. By providing this consent, you authorize the handling of biological samples and health information that concern you for the purposes of the study by any persons involved in the research (health personnel, data managers, statisticians, inspection staff of regulatory agencies and those authorized by the study protocol and / or by current laws). In this case, any information concerning you will, in the event, be published only in anonymous form, carefully and rigorously avoiding and any detail that may in some way allow third parties to trace your identity. In addition, the data relating to you will be stored in accordance with the protection measures foreseen by the Law.
Clinical trial: NCT03294122
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Would Participating In This Study Be Harmful To Me?|Guarantees For The Protection Of The Patient Participating In The Clinical Trial.

MICRO-LEARNER is an observational study so your treatment will not change by choosing to take part in this study. As indicated above, you will be asked to complete some questionnaires and to give a blood/saliva/fecal samples. Potential harms of taking blood are haematoma or extremely rarely impairment of nerves. If you are harmed by taking part in this research project, the insurance policy stipulated by this Foundation guarantees a specific coverage, in accordance with current legislation

The study was approved by the independent Ethics Committee at the National Cancer Institute in Milan.  
Biological samples will be processed, stored and analyzed under the responsibility of: Dr. Loris De Cecco, Department of Experimental Oncology and Molecular Medicine and Dr. Nadia Zaffaroni, Department of Molecular Pharmacology Fondazione IRCCS Istituto Nazionale dei Tumori, Via Amadeo 42, Milan Your decision as to whether or not to take part in this study is completely of your free will. This means that if you decide not to take part in this study this will not affect the care you receive at this institution. A copy of this Information Sheet and a copy of any possible Consent will remain in the possession of the Patient who agrees to participate in the study.  
Information and demonstration of consent to the processing of personal data
(following resolution no. 52 of 24/7/2008 Guidelines for the processing of personal data in clinical trials of drugs)
Clinical trial: NCT03294122
Section: Procedures
Subsections: What Will Happen To Me If I Do Take Part?

If you decide to take part in this study, you will be seen by a member of the research team at the beginning of your radiotherapy treatment who will then ask you to complete some questionnaires asking about symptoms you may be experiencing before you start your radiotherapy treatment and about your general well-being. You will then be asked to complete the same questionnaires again when your radiotherapy is finished and then at routine follow-up appointments at least twice a year for at least three years after your treatment. This is a practical and reliable way for us to measure and record the effects of your radiotherapy treatment. These questionnaires should preferably be completed in the clinic (but could be done at home) and take no more than 20 minutes to complete each time If you are receiving treatment for prostate cancer, we will ask you to collect two fecal samples for the analysis of your gut microbiome. They are to be collected at home using a kit that will be provided by the healthcare staff. One sample will be collected before the radiotherapy and one at the end of the treatment.  
We will also ask you to provide us with three blood samples, one before the beginning of radiotherapy, one after two weeks of treatment, and one at the end of the radiotherapy. Each time, we would like to take a maximum 20 ml of blood, which is less than three tablespoons and similar to the amount taken for routine blood-testing. Then, you'll be asked to perform a multi-parametric magnetic resonance one year after the end of the radiotherapy treatment. This is a very advanced imaging examination that will allow us to investigate how your tissues have responded to radiotherapy.  
If you are receiving treatment for a head-and-neck cancer, we will ask you to collect two samples of saliva for the analysis of your salivary microbiome using a kit that will be provided by the healthcare staff. One sample will be collected before the radiotherapy and one at the end of the treatment. We will also ask you to provide us with three more saliva samples, one before the beginning of radiotherapy, one after two weeks of treatment and one at the end of the radiotherapy, and a blood sample before treatment. we would like to take a maximum 20 ml of blood, which is less than three tablespoons and similar to the amount taken for routine blood-testing. If you have an oropharynx cancer, you will also be asked to perform a multiparametric magnetic resonance after two weeks of radiotherapy. This is a very advanced imaging examination that will allow us to investigate how your tissues are responding to radiotherapy.
Clinical trial: NCT03294122
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

The purpose of this study is to try to predict which patients who receive radiotherapy are more likely to have side effects than others. Approximately half of all cancer patients receive radiotherapy as part of their cancer treatment. The dose of radiation given, however, is limited because of a risk of damaging the healthy cells that surround the tumour. Patients vary in how they react to radiation. About 5% of patients (5 out of every 100) are sensitive and at risk of having side effects.  
In recent years, researchers have developed predictive models and biological tests to try to identify before the start of treatment those patients who are very sensitive. However, these methods are not yet ready to use in the clinic so radiation doses for all patients are currently limited by the doses the most sensitive patients can have. The observational study MICRO-LEARNER addresses the issue of individual sensitivity to radiation with an innovative approach. In particular, we propose to study the composition of the gut and salivary microbiome at the individual level. The microbiome is the population of microorganisms that live in balance within our organism. There are some studies that show that these microorganisms are important in determining the individual sensitivity to radiation. The main purpose of MICRO-LEARNER is to determine whether there is an association between the type of microbiome of single individual and his/her probability of exhibiting side effects of radiotherapy.  
We hope that results from this study will improve current predictive models and biological tests to predict how a patient will respond to radiotherapy. If we are successful, then in future we could identify the
'radiosensitive' patients before they start their radiotherapy In the long term, our ultimate hypothesis is that information on the individual microbiome before radiotherapy could allow a modification of the microbiome itself in particularly susceptible patients, thus reaching an advantage for future patients. Sensitive patients could potentially be safely and effectively treated after modification of their microbiome, and other patients could be treated with more radiation. This should reduce side effects for all patients, improve quality of life and potentially increase the number of patients successfully treated for their cancer.
Clinical trial: NCT03294122
Section: Voluntary Participation
Subsections: Why Have I Been Chosen?|Do I Have To Take Part?|Informed Consent To Participation In The Biological Study To Personal Data Processing

You are invited to take part in this study because you were recently diagnosed with prostate or head-andneck cancer and your doctor has recommended that you should receive radiotherapy. The MICROLEARNER study needs 400 patients in total to take part. All patients will be enrolled at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan

No, it is entirely voluntary. If you decide to take part, please keep this information sheet and sign a consent form to show you agree to participate. We will also ask your permission to tell your family doctor that you are taking part in the study. If you do take part, you can withdraw at any time and without giving a reason. A
decision to withdraw, or a decision not to take part, will not affect in any way your treatment or the standard of care you receive now or in the future.

This form must be signed by you only if you decide to participate in the clinical trial.  
It is important that you have discussed in depth with your doctor before signing this consent, including discussion of the Patient Information Sheet describing this trial.  
Only Patients who accept this Consent will participate in the study.  
A Patient can withdraw his consent at any time.  
I confirm that I have read and understood the MICRO-LERNER patient information sheet for the above study and have a copy to keep. I was able to consider the information with the doctor, ask questions and had them answered satisfactorily.  
I give my free and informed consent:
to participate in this clinical trial to processing of my personal and medical data, in paper and electronic format, in compliance with the regulations in force, inter alia of Decree 196/2003 and subsequent modifications to integration of the consent already signed by me to processing of my sensitive data at the National Cancer Institute in Milan to the collection, storage, and use of biological samples to carry out research following the previously detailed conditions Any resolution that is not specified in the attached information sheet cannot be made, unless a new Ethics Committee's approval is obtained. In this case the Ethics Committee will decide whether it is necessary to obtain a new consent from me.  
The results of the analysis will only be published in anonymous form and aggregated with the results of the analysis of other patients. I have the right to request the destruction of samples, if not already used, and only for the time when this is technically possible, especially until they have been completely anonymized.  
There will be no information available to me or to my doctors about the results of the tests on my biological samples, given their experimental character, but I may ask (even now) to be informed about the results of this biological study, as well as those of the main clinical trial.  
Signature of the researcher taking the consent ………………………………….………  
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Printed name ………………………………….………
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Signature of the patients ………………………………….………
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Date: …../…../………. Signature of Legal Representative or Tutor (if applicable) ………………………………….………  
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Date: …../…../………. Signature of Witness **(if applicable)** ………………………………….………  
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Clinical trial: NCT03294122
Section: Withdrawal from Study
Subsections: What Happens To My Samples And Information If I Decide To Withdraw?

You can withdraw at any time and without giving a reason. If you decide to withdraw your coded blood samples and information will be retained for use in this study and for future medical research unless you specifically request otherwise. If specifically requested, your samples will be destroyed and your medical information removed from the MICRO-LEARNER database.