| Fact sheet
What is the CTB?
What types of material and information is
available from the CTB?
Who can obtain material and/or information from the CTB?
How do researchers apply?
How are requests evaluated?
What are the criteria for evaluation and
review of applications?
How do I get an answer to any other queries?
Download this factsheet as a
Word Document
What is the CTB?
The CTB is an international cooperation to establish
banks of material from and information on patients who were
exposed as children or adolescents to fallout from the Chernobyl
nuclear accident. The project is supported by the governments
of 2 of the 3 countries which were exposed to the heaviest
contamination from the accident: the Russian Federation and
Ukraine. Belarus, which was also contaminated and was initially
part of the CTB, is currently suspended because of political
issues. Funds to support the bank are currently provided by
the European Commission, the National Cancer Institute of
the USA and the Sasakawa Memorial Health Foundation of Japan.
The Coordinating Centre for the project is based at Imperial
College, London, UK.
The project commenced collection of material on 1st October
1998. It is designed to promote collaboration and avoid wasteful
competition in the use of limited and very scientifically
important resources. The project is overseen by a Steering
Committee, which includes the Ministers of Health or their
representatives from the Russian Federation and Ukraine and
senior representatives of each of the funding organisations.
The objectives of the project are to provide an internationally
supported research resource for both ongoing and future studies
of the health consequences of the Chernobyl accident. It aims
to:
1. Ensure that specimens of thyroid cancer operated on or
after 1st October 1998 (the start date of the project) are
consistently described and sampled, and that the materials
(extracted tumour and normal DNA/RNA and blood samples and
in some cases fixed tissue sections) together with the relevant
information, are available for appropriate research studies.
2. Provide a diagnosis agreed by an international committee
of pathologists for all cases in the CTB. The diagnosis will
be made available to research groups carrying out molecular
biological, therapeutic, epidemiological and other studies
as well as to the countries concerned.
3. Ensure that knowledge pertaining to the consequences of
this accident that may benefit the patients involved, or mankind
in general, and be of value in responding to future nuclear
accidents is not lost.
What types of material and information is available
from the CTB?
The bank includes material and information from patients with
thyroid carcinomas and cellular adenomas from the contaminated
oblasts of the Russian Federation and Ukraine who were born
after 26th April 1967 (i.e. aged under 19 at the time of the
Chernobyl accident) and operated on or after 1st October 1998.
The tissue banks which comprise the CTB are held in the Institute
of Endocrinology and Metabolism in Kiev, Ukraine and the Medical
Radiological Research Centre in Obninsk, Russia. Detailed
standard operating procedures for the collection, documentation
and storage of specimens and blood samples have been agreed
with professional staff involved in the collection of material.
Ethical standards, conforming to the requirements of the country
involved, including those of the funding organisations have
been agreed with the relevant authorities.
Standard operating procedures for the collection of information
and material have been approved by the relevant Institutional
Review Boards. Each specimen is given a code authorised by
the appropriate person responsible for the management of the
bank in each of the three countries. The age, sex, date of
birth, date of operation, oblast and country of residence
is recorded for each specimen stored in the bank and made
available to researchers with approved projects receiving
material from the bank, together with the review diagnosis
agreed by the international panel of pathologists.
Frozen aliquots of DNA and RNA extracted from normal and
neoplastic thyroid tissue and DNA extracted from blood, are
available. A frozen section is taken from each portion of
tissue before extraction to verify its nature. DNA and RNA
are extracted to an internationally agreed protocol. Quality
control is performed on nucleic acid extracted from all tissues
and blood samples. In addition, sections from paraffin sections
and from sections of tissue microarrays are available.
Go to Top
Who can obtain material and/or information from
the CTB?
Samples of extracted DNA and RNA from tissue, DNA from blood,
samples of serum, paraffin embedded sections and tissue microarrays
are available to the international scientific community. Researchers
must apply to the CTB on the forms provided (available through
the web site) for use of the resources. It is not the aim
of the project to restrict supply of material to researchers,
but to coordinate and monitor the use of this unique resource
in order to ensure that the maximum possible information can
be obtained from a limited supply of material.
Go to Top
How do researchers apply?
Researchers who are interested in using material or information
from the CTB for research must complete a brief, but detailed,
proposal that includes information on the study design and
requirements for materials or data.
Applicants whose projects are approved are encouraged to
cooperate with the Institutes in Ukraine and Russia depending
on which Institute's material is most suitable and is available.
For major collaborative studies, a period of training for
a member of the relevant Institute’s staff may be recommended,
and allowance in the application to funding bodies for financial
support may need to take account of this and other costs.
No charge is made for samples of nucleic acid, but researchers
must be prepared to pay appropriate expenses for shipment
of specimens. Any request which may involve the relevant Eastern
European Institute in work additional to the collection of
samples for nucleic acid extraction and the minimal data set,
will also attract an additional charge. Prospective applicants
who are not yet in receipt of funding, or who are in the process
of obtaining funds, are strongly encouraged to contact the
CTB Secretariat to obtain information on resource availability.
The CTB does not provide funding for research projects.
Go to Top
How are requests evaluated?
Requests are evaluated for scientific merit and appropriate
use of CTB resources by the External Review Panel (ERP), which
is an independent, multi-disciplinary panel of senior researchers
in the fields of thyroid cancer and radiobiological research.
The External Review Panel awards scores for various aspects
of an application, which are then averaged. Based on the score,
an application will be assigned to one of three categories:
(i) approve for access, (ii) the PI to be invited to respond
to the ERP’s comments, or (iii) reject. The Chairman
of the SAB will be advised, for information, of applications
scoring in categories (i) or (iii), but will review applications
about which questions have been raised and/or for which the
PI’s response requires further consideration. The Chairman
may seek views from other members of the SAB. The CTB Steering
Committee will be the final arbiter in cases where the Chairman
of the SAB is unable to reach a decision. Projects may be
submitted at any time and the review procedures are, in most
cases, completed by e-mail.
Go to Top
What are the criteria for evaluation and review of
applications?
Criteria have been established to ensure that valid, productive
and equitable scientific use is made of the CTB resources
for multidisciplinary and international studies on post Chernobyl
thyroid cancer. Approval for a project may be subject to the
development of appropriate collaborative links. Collaborative
publications between Eastern European Institute personnel
and researchers using material provided by that Institute
are anticipated.
Researchers applying for CTB resources must provide evidence
that the following criteria are satisfied:
1. The question being addressed is of considerable scientific
and/or medical interest.
2. The study design is appropriate to address the question.
3. The sample size is sufficient to provide a good chance
of answering the question.
4. The researcher and his/her research team have appropriate
qualifications and experience to conduct the study.
5. The researchers are familiar with the relevant literature.
6. The proposed work cannot be undertaken without the data
and/or materials of the type collected by the CTB.
7. The researchers have provided sufficient evidence to the
External Review Panel that they can perform to accepted standards
and quality control, the relevant laboratory analytical procedures.
8. If data other than the standard data set (date of birth,
date of operation, sex, oblast of residence and international
pathology panel review diagnosis) are required, the costs
of obtaining this data and ethical and consent issues should
be adequately addressed.
9. The researchers are able to obtain sufficient funds to
pay for the shipping of Material. Cost estimates will be provided
by the Secretariat, based on Steering Committee guidelines.
10. The researchers, or their collaborators, can perform
and interpret properly the appropriate statistical methods
required for the study.
11. The researchers identify suitably qualified and trained
persons to perform the work, and agree that only these persons
will have access to the data and material.
12. The amounts of material requested by the researchers
are appropriate for the specified study, and are not excessive,
given the limited availability of material.
13. The research can be undertaken within the time consistent
with the researcher’s funding and the availability of
the necessary data and materials.
14. Any potentially clinically relevant data uncovered during
the course of the study will be passed to the CTB Secretariat
immediately who will pass the information on to the appropriate
centre, through the channels agreed by the Steering Committee.
15. The researchers agree to provide within 3 months of the
completion of their research project, a brief report on their
work, including the results of their investigations on each
sample studied, identified by the CTB sample code number.
This information will be sent to the CTB Secretariat for use
within the CTB. It will not be otherwise disseminated without
the agreement of the Principal Investigator.
16. The researchers will inform the CTB Secretariat if any
material has not been used in the performance of their designated
study and will return this material, if requested, to the
Secretariat for transmission to the appropriate Eastern European
Institute.
17. The researchers agree not to use the material for any
use other than that explicitly proposed in their approved
project, or to pass any material supplied by the CTB to third
parties without the explicit permission of the Scientific
Advisory Board.
Go to Top
How do I get an answer to any other queries?
If you have any questions that are not covered in this fact
sheet, please contact the CTB secretariat and we will do our
best to help you:
CTB Secretariat:
Dr AR Galpine
Project Manager Chernobyl Tissue Bank
Department of Histopathology
Imperial College London
Hammersmith Hospital
Du Cane Road
London W12 0NN
Tel +44 (0)20 8383 2443
e-mail: a.galpine@imperial.ac.uk
|
