Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03473912 |
| Other study ID # |
MMC17-0116CTIL |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2018 |
| Est. completion date |
November 2037 |
Study information
| Verified date |
March 2019 |
| Source |
Meir Medical Center |
| Contact |
Yair Levy, Prof. |
| Phone |
972-9-7471524 |
| Email |
levy.yair[@]clalit.org.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with
rheumatoid diseases. These samples will later be used for clinical and basic research,
following approval of each specific study by the IRB. The investigators intend to extract
protein, DNA and RNA from each sample.
Description:
1. PURPOSE Rheumatic diseases, being part of the auto-immune diseases, are rare
inflammatory diseases which usually occur from an unknown reason. Various factors alone
or in combination can trigger the disease, including pathogens, medications and stress,
but the most prominent factor is the genetic background. These diseases are chronic,
characterized by periods of flares and regression, and patients are often treated by
various drugs. In routine check-up visits in the rheumatology clinic, patients are
giving blood regularly in order to monitor the levels of cytokines and antibodies.
However, the factors being assessed in the routine lab are limited, and the
investigators believe there are much more proteins that can be studied in our research
lab. Genomic studies of DNA and RNA isolated from blood of rheumatic patients are rarely
being performed, and if they are - only at diagnosis. Combining both protein and genetic
profiles of patients at diagnosis and follow up can be extremely useful both for basic
and clinical research in helping us to understand the tendency to develop a disease, as
well as disease progression and response to therapy. A rheumatoid bio-bank is the basis
of establishing many studies leading us a step forward towards personalized medicine.
2. DNA/ RNA resource DNA and RNA will be isolated from blood, synovial fluid or from skin
tissue biopsies, related to the rheumatologic disease, derived from patients and normal
donors who consent to participate in the rheumatologic Bio-Bank program. The DNA/RNA
will be extracted, measured and stored in the bio-bank freezers. Blood samples will be
drawn by a physician or accredited nurse, synovial fluid samples and skin biopsies will
be collected by physicians only.
3. Patient recruitment: Obtaining Informed Consent
General Principle:
Tissues will only be taken from adult patients who gave consent by means of a signed
informed consent form.
All patients above the age of 18, referred to the Rheumatology clinic or Internal
Medicine E Department at the Meir Medical Center, for investigation or treatment of
suspected rheumatic disease, will be candidates to participate in the repository.
Patients at their primary diagnosis or follow up will be eligible for this study.
Recruitment of patients and obtaining informed consent will be done by physicians only.
No tissue for DNA/RNA isolation will be taken from patients prior to obtaining their
written consent or from those who do not consent.
Number of sample in the bio-bank: 500 for each year
4. Identifying Patients Entitled for Sample Collection 4.1 - General responsibility: The
bio bank manager, Dr. Yair Levy, will hold responsibility for appropriate storage and
privacy protection of samples, and will be in charge of the bio bank staff.
4.2- Privacy protection and access to patient's information: To protect patient's
privacy identification, a serial code will be generated for each sample. The serial code
will replace patient's identifying stickers and along the bio bank processing, samples
will only be recognized by bio bank serial codes. The samples are stored in locked
freezers or in freezers located in locked rooms accessible to bio bank staff only. The
protocol for sample coding: Names and ID numbers of all consented patients will be saved
at the bio bank in a separate database that is not connected to the bio bank sample
tracking system. On sample reception to the bio bank, the serial code and the correlated
patient's identifying number will be recorded on a special secure computer file within
the bio bank records. Access to this file will be restricted only to the bio bank
coordinator or its manager. All paper documents containing data about patients or
samples (e.g. a copy of patients informed consent form) will be kept in locked cabinets.
4.3 - Coordinating sample collection: The nurse will draw blood according to physician's
orders and the attached bio bank forms. Synovial fluid aspirates will be taken solely by
physicians and only if medically indicated.
4.4 - Skin biopsies - The bio bank coordinator will be informed on a weekly basis of all
planned skin biopsies at the Dermatology clinic at Meir Medical Center. The biopsy will
be performed as clinically needed and with no modification due to banking requirement.
All removed tissues will be sent to the pathology lab and processing for banking will
begin only after confirmation that adequate tissue is available for the pathology
processing. Tissues that eventually will be diagnosed other than rheumatic related
disease will be banked and may serve for studies of that specific process or as
controls.
5. Participant's rights 5.1 Benefits and risks to participants The impact of human genetics
research on human beings is vast. DNA samples taken from patients and volunteers may
carry information regarding genetic disorders, inheritance pattern and also about the
human nature. The focus of the rheumatologic Bio-bank is on rheumatoid diseases
pathogenesis, therapies and immune response during illness and recovery. Samples stored
at the Bio-Bank may be subject to any genetic study of rheumatoid diseases regarding the
biology, pathogenesis, prognosis, complications or patient's response to the disease or
therapy. The benefit outcome from genetic studies to the individual participant may be
detection of clinically significant genomic markers which may have implications for
patient's appropriate treatment, and follow-up. The risks might include bad mental
influence according to one's genetic aberration detected.
5.2 Withdrawal of participance Participants who want to withdraw their consent must
inform the Bio-bank their request in a written letter. Following the acceptance of
participant letter, the use of his samples will be immediately stopped and all available
DNA samples from this participant will be discarded. In case that a DNA sample from this
participant had already been utilized for a specific study, the Bio-bank manager will
inform participant request to that study PI which must stop using that sample.
5.3 Patents rights Participants won't have patent rights or spiritual asset derived from
studies that use their samples.
5.4 Participant's compensation Bio-bank donation will be voluntary only. No compensation
will be paid to participants.
6. Timing for Sample Collection and Processing Preferably, the first sample collection
should be collected at diagnosis. From patients presented during weekends and holidays
the consent will be obtained at admission but samples will be taken early in morning on
the first regular working day. It is important that first samples be collected prior to
the first drug administration or at least as close to the beginning of therapy as it is
possible. By no means will the treatment be delayed for any reason related to this
protocol.
Pre-set regular follow-up time points and major clinical events (flare, relapse, and
remission) will serve as important milestones. Samples will be drawn simultaneously with the
routine clinical tests as ordered by the treating physician. By no means will sample be taken
if not otherwise indicated and ordered by the treating physician. All samples should be
transported to the laboratory immediately after they had been drawn. Processing should begin
as close to the time it was drawn as is possible. Sample Handling protocols 7.1 Sample
collection: Blood samples are taken only from participants who have previously consented and
authorized the use of their samples for research purposes. Blood will be drawn by any
employees certified in taking blood at the Meir Medical Center; synovial fluid will be drawn
by physicians only. Blood and synovial fluid will be drawn to lavender and gold top vials
with EDTA at a maximum of 20 ml for blood and 30 ml for synovial fluid.
7.2 Blood Processing: Blood samples will be separated to serum and cellular fraction by
centrifugation, and kept at -80c until used. White blood cells (WBC) will be collected
following red blood cells hemolysis, and stored at -80c. Proteins will be assessed directly
from the sera fraction while DNA/RNA will be extracted from WBC.
8. Utilization of frozen sample A. Appreciation for usage of frozen sample
All researchers working at Meir or in any other recognized research institution are
potentially eligible for samples use from this protocol. No personal identifying data will be
given. A summary of relevant clinical data on the donor of each sample will be enclosed,
without any personal data such as name, ID number, hospital record number, address or
telephone number. A sample will be eligible for utilization only after the completion of all
the following conditions:
1. A written confirmation from the Internal Review Board (IRB) and the head of researcher's
institute, approving the specific project / experiment, for which samples are required.
2. The PI of the suggest experiment will present a detailed protocol of the suggested
experiment. The protocol should include the rationale and the expected benefit from the
experiment, clear and detailed inclusion and exclusion criteria and detailed laboratory
protocol.
3. The PI of the suggest experiment will provide a written document listing all samples
received for his/her research, confirming his/her obligation and responsibility to
follow all ethical roles as detailed by Israeli law and Meir's IRB. The PI of the
suggest experiment will not transfer samples to a third party without permission from
the Bio-bank manager and the Meir's IRB.
4. The transported samples must be unidentified. Only the Israeli Bio-bank manager will be
able to decode the samples information in case it will be needed.
5. The Meir IRB will review all the above documentation and will approve utilizing samples
from the Bio Bank.
B. Protocol of tissue usage
Following the completion of all required conditions as mentioned in paragraph A, the PI of
the project or experiment should fill out a tissue request form and submit it to the Bio
Bank. PI of the Bio Bank project is responsible to verify that all required conditions were
fulfilled. The following protocol is to follow:
1. The bio bank coordinator will confirm with the PI who applied for samples when his
laboratory team will be ready for picking up samples.
2. Samples will be always dispatched frozen in sealed boxed with dry ice. Samples will be
marked with a printed sticker of bio bank barcode of that sample. A detailed summary of
the clinical follow up of all patients who donated samples for this project will be
attached identified by bio bank barcode only. Names, ID numbers of any other identifying
details will not be provided.
C. Utilizing samples priorities and the role for long term banking
1. In case concomitant projects are interested in identical samples: Projects that runs by
investigators from Meir Medical Center will be prioritized over projects from other
institutes.
2. RNA and DNA will be preferably reserved for large scale studies. International
collaborations are welcomed to utilized samples for studies within the scope of this
protocol.
3. Samples will be saved as identified samples (as described in 4.2) for 20 years from the
end of collection. After 20 years samples will be destroyed unless extending storage
duration will approved by Helsinki Committee.
