Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02127359 |
| Other study ID # |
12-078 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2012 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
February 2021 |
| Source |
Dana-Farber Cancer Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Cancers occur when the molecules that control normal cell growth (genes and proteins) are
altered. Changes in the tumor genes and in the genes of normal cells are called
"alterations." Many of these alterations can be detected by directly examining cancer cells
in a tumor or circulating in blood. Several alterations that occur repeatedly in certain
types of cancers have already been identified. These discoveries ahve led to the development
of new drugs that "target" those alterations. More remain to be discovered.
Some of the alterations are found in genes. Genes are composed of DNA "letters," which
contain the instructions that tell the cells in our bodies how to grow and work. Genes make
proteins which actually carry out the instructions in our cells.
We would like to use your DNA to look for alterations in the genes in cancer cells and blood
cells using a technology called "sequencing." Gene sequencing is a way of reading the DNA to
identify errors in genes that may contribute to the behavior of cells. Some changes in genes
occur only in cancer cells. Others occur in normal cels as well, in the genes that may have
been passed from parent to child. This research study will examine both kinds of genes.
The purpose of this research study is to perform gene sequencing (gene tests) on your cancer
cells (obtained from biopsies or surgery) and normal tissues (usually blood). The results of
the gene tests will be used to try to develop better ways to treat and prevent cancers. We
will also study better ways to communicate the results of these complex gene tests to you and
your doctors, and to help you and your doctors use this information to choose the best paths
for treatment. As part of this work, we may also learn things about the genes in your normal
cells; some of that information will also be shared wtih you and your doctors if you so
choose.
Importantly, this study will use tissue specimens that have already been collected and stored
in the pathology department as part of your clinical care or as part of other research
studies you may be participating in. In this study, gene tests will be performed on material
only after the necessary clinical tests have been performed. In general, no additional
invasive procedures will be required.
Description:
If you agree to take part in this study, we are asking your permission to obtain an
additional sample of blood (2 tubes or 4 teaspoons). Cells from the blood contain normal,
non-cancer cell DNA which is needed for the analysis.
One of the main reasons to study the genetic characteristics of cancers is to learn whether
they can predict response to existing treatments. Therefore, in this study, we would also
link the results of gene tests on your cancer wtih medical information that has been
generated during the course of your treatment. The medical information is contained in your
medical record.
A small number of the gene test results may have importance for your health or treatment. For
example, they might uncover gene alterations known to make cancers respond to (or be
resistant to) specific therapies. Therefore, we are asking you to consider whether or not you
would like us to inform your doctor and you about some of the results of these gene tests.
Your doctor may contact you about results of gene tests, but only if the results could impact
your cancer treatment or other disease directly, or if you have given your permission for him
or her to do so. In some cases, a research doctor may contact you to find out if you would be
interested in participating in a different research study based on information thay may have
been found in your tissue or blood samples, or in your survey/interview responses. We will
also ask you to provide the name and contact information for a relative who may know your
whereabouts, or who could decide about using your information for research in the future, if
you are not available to give permission yourself.
Some of your specimens, as well as some of the material generated during the analysis of your
tissues or blood, may be useful for study in the future, with newer technologies and
approaches. We are asking your permission to store these specimens and materials in a secure
biologic sample storage facility for possible later research.
We are also asking you to participate in two surveys related to the study at a few time
points. These time points include when you first join the study, and after you receive any
results from the gene tests done on your samples. The surveys seek to learn how you are
thinking about this type of genetic analysis, and the ways in which the information can be
shared with you that would be most helpful.
Some study participants will also be invited to take part in study-related interviews. The
purpose of these interviews is to understand what you expect will happen as a result of the
gene tests, and how the results of the gene tests may have affected you.
The surveys should take no more than 15 minutes to complete. The interviews are expected to
take approximately 45 minutes to complete.
Finally, rapid progress in understanding and treating cancer will occur when some of the
genetic information derived from your tissues and blood can be shared with other researchers.
In particular, the National Institutes of Health (NIH) and other organizations have developed
special data (information) repositories that analyze data and collect the results of certain
types of genetic studies. These central banks will store your genetic information, samples,
and survey/interview information and provide them to qualified researchers to do more
studies. Therefore, we are also asking your permission to share your results with these
special banks. Your information or samples will be sent only with a code number attached.
Your name or other directly identifiable information will not be shared with data banks or
other investigators. There are many safeguards in place to protect your information and
samples while they are stored in repositories and used for research. although there may be a
slight risk of loss of privacy when sharing this information with these banks, we have
established procedures to encode your samples and information and protect your data. Although
we will do everything we can to protect the privacy of your data, we cannot absolutely
guarantee its privacy or predict how genetic information will be used in the future.
