PATIENT INFORMATION NOTICE
Title of Research study:
Genomic profile of primary non-small lung cancers and invaded mediastinal lymph nodes (GPN2).
Your disease needs to be treated by surgery. That’s why, following your doctor’s proposal and your
own accept, you are eligible to be included in this research study.
Before your participation to this biomedical research study it is important to read this document
providing information about the research study development.
After a proper thinking period you may give your accept.
RESEARCH STUDY OBJECTIVE
This research study shall be made on 100 patients recruited during the last 3 years in France, Austria
and Romania and grouped on 4 thoracic surgery services.
The main objective of the research study is to study the genetic mechanism leading to the
appearance of your disease. A better understanding of such mechanism would allow the
identification of new diagnostic and prognostic markers and new therapeutically target. These things
would allow the improvement of the treatment to be applied in the future to patients suffering of
same disease as you.
By participating to this research study, you will effectively contribute to the research effort able to
help people in your position.
PROCEDURE DESCRIPTION
In the usual treatment applied to your disease, the surgery will excise the ill part of your lung. This
excised tissue shall be sent to the Pathological Anatomy Laboratory of the hospital to make samples
of the tumor, lymph nodes and health lung. A part of these tissues shall be frozen and conserved at 80°C according to the recommendations of the National Institute of Cancer while the other part shall
serve to establish the diagnostic of your disease with the microscope.
We request your accept for sampling, in the Pathological Anatomy Laboratory of the hospital,
supplementary tissues, healthy and ill, from the material excised, to be used in this research study.
If you accept to participate to this research study, the relevant fragments shall be anonymous, being
identified by a code attributable to them, then they will be frozen and conserved at -80°C, being sent
by a special transport, to the Genome Laboratory of the Fundeni Clinical Institute in Bucharest,
Romania, to be studied the genic expression on each type of tissue.
Then, the Research Institute for Cancer of Vienna, Austria,
shall analyze the data obtained and shall validate the
results.
If you accept to participate to this research study, in the surgery morning, before going to the
surgical ward, a supplementary quantity of 20 ml of urine shall be taken, and during the surgery, 18
ml of blood shall also be taken. These samples do not represent any risk for you and shall have no
effects on your health.
Your participation to this research study shall limit to the period during which the urine and blood
are sampled.
During this research study, with your prior accept, the following medical examinations shall be
carried out:
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a genetic analysis on the tumor, tumor’s lymph nodes and healthy pulmonary tissues;
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an analysis of the protein markers of the genic expression found in your urine and blood.
The blood, urine, pulmonary tumor, pulmonary tissues and lymph nodes sampled and used in the
research study to analyze the genic expression shall be kept 13 years in the Genome Laboratory of
Fundeni Clinical Institute in Bucharest, Romania, under the coordination of Professor Doctor Irinel
Popescu, the Head of the Laboratory.
At this term expiry, the samples shall be destroyed by incineration. These samples shall not be used
under any circumstance to other research studies.
Your participation to this research study shall not generate any charge for you supplementary to
those related to the treatment of your disease, already approved by you.
This research study was endorsed by the Committee for the Person Protection of Ile-de-France V, on
……………………………, according to the provisions of Article L. 1121-1 of he Public Health Code.
POTENTIAL RISKS
The only risks of your participation in this protocol are discomfort of a blood test ; the surgery is not
part of the study itself.
CONFIDENTIALITY
All personal data obtained during the research study shall be treated as anonymous and confidential.
To analyze the results of this research study, your medical data shall be transmitted to the research
study developer or to its duly representatives, natural or legal persons, in France or abroad. These
data shall be identified by a code. Your identity shall not be specified in any moment and your
biologic samples shall remain anonymous.
The authorities and the research study developer’s representatives may access your medical file
observing the confidentiality and legal pre-requisites to control the accuracy of the data collected.
According to the legal provisions related to the data computerized processing, file and liberties of 6
January 1978, you are entitled by law to access and rectify your data by addressing in any moment
your doctor responsible for the research study. You also are entitled to opposite to the transmission
of your personal data subject of professional secret which might be used and processed in this
research study.
Also you may access, directly or through a doctor selected by you, the file with your medical data,
following the provisions of Article L1111-7 of the Public Health Code. You may exercise these rights
against the doctor monitoring you within the research study and knowing your identity.
You are free to participate or not to participate to this research study. You may reserve your right to
interrupt in any moment your participation to the research study without any justification and any
adverse effect on the healthcare services provided to you.
The medical data shall be published by strictly observing the anonymity of the patients.
RESEARCH STUDY RESULTS
You are entitled to be informed about the global results of this research study. You may obtain the
results, when available, from your research investigator doctor.
RESEARCH STUDY ORGANIZATION AND FUNDING
Ministry of Education and Research of Romania – Romanian National Authority for Scientific
Research, 21-25 Mendeleev Str., 010362, 1st district, Bucharest, telephone: +40-21-319.23.26,
+40-21-319.23.27, +40-21-319.23.28, e-mail: media@ancs.ro.
You do not bear any cost. The research study developer bears all the expenditures related to the
research study.
After reading this information notice and receiving the answers to your potential questions from
your monitoring doctor, this one will propose you to give us your written consent by signing the
Consent Form especially draft.
FIRM CONSENT FORM
Patient Code Number :
I, the undersigned,
Mrs., Mss., Mr. (check the proper mention)……………………………………………………
accept freely and willingly to participate to the biomedical study with the title « Genomic profile of primary
non-small lung cancers and invaded mediastinal lymph nodes (GPN2) »
whose developer is the Ministry of Education and Research – National Authority for Scientific Research,
Romania, proposed me to participate, through the doctor (name, forename, telephone )
…………….…......................................................................................................., doctor participating to the
research study.
I state that:
-
-
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The doctor who informed me and answered to all my questions, specified me that my participation is free
and that I may exercise in any moment my right to withdraw from the research study,
I authorize carrying out genetic research on my tissues excised during the surgery,
I benefited, before the participation to this research study, of a medical examination whose results were
communicated to me,
I may control the data concerning my health status, at the research study initiation or during the research
study, held by the doctor monitoring my research study participation, through this one,
I am informed that I have the right to withdraw anytime my consent to participate to the research study
without any other liability except to inform the doctor responsible for my participation. Cessation of my
participation to this research study shall not affect in any way my relation with the doctor responsible for
me,
I am informed that I may request the access, through my doctor, to the global results of the research study,
when available,
My accept shall not release my doctor and the research study developer of their liabilities and I reserve all
the rights granted to me by law,
I did not receive, directly or indirectly, any remuneration, regardless its nature, in exchange of my
participation to the research study.
If necessary:

I agree with the computerized processing of the data recorded during this research study, containing
personal genetic data by or on behalf of the research study developer. I acknowledge that the data
access right set out in Art. 39 of the Law on data computerized processing, files and liberties of 6
January 1978 may be exercised anytime against the doctor monitoring me and knowing my identity. I
also may exercise the right to correct the data and to oppose to their transmission, through the same
doctor who, on his/her turn, shall contact to this purpose, the research study developer.
Patient Name and Forename:
Date:
Issue Date:
Signature
Signature of the doctor, certifying that the patient was informed about the research study objective, methods
and potential risks.
Date:
Signature
Document made in 3 original copies, the first being kept 15 years by the investigator, the second being handed in to
the patient giving his/her participation consent and the third being sent to the research study developer.