Biopsies of Cancer Patients for Tumor Molecular Characterization



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/28/2018
Start Date:February 2010
End Date:January 2018

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In this research study, we are looking at performing a repeat biopsy of patients' tumors,
even though they have already been diagnosed with cancer. The tumor tissue obtained from the
biopsy will be studied to see what it looks like at the molecular (genetic) level. By
conducting this study, we hope to learn more about how cancers work, why cancers respond to
certain treatments, and how they become resistant to certain treatments. We also hope to
demonstrate that biopsies like this can be performed safely in large numbers of patients. The
research done on the tumor samples may help us identify which patients in the future are most
likely to respond to new cancer therapies.

- In order to participate in this research study, participants must have already been
diagnosed with cancer. The cancer must be located in a part of the body that is
accessible for a biopsy and the doctor that will perform the biopsy must agree that the
participant is a good candidate for biopsy. The biopsy will be done in the usual way, as
part of your standard medical care.

- After the biopsy, the participant will return to the clinic approximately one week later
for a check on their status. At this visit participants will be asked questions about
your post-biopsy health. We will continue to follow-up with the participants by phone or
at subsequent clinic visits for one month following the biopsy.

- The biopsy obtained will be studied in the Translational Research Laboratory at
Massachusetts General Hospital, where it will undergo a panel of genetic tests. These
tests look to find out what is driving the cancer or making it tick. It is important to
understand that the genetic tests we will do include a number of cancer related genes or
proteins that may be important for making treatment decisions, either now or in the
future. The test results may or may not show a finding that could affect the
participant's treatment options. There will be no specific testing done for inherited
genetic abnormalities, so undergoing this research will not give information about the
risk of cancer for people in the participant's family.

- If there is left-over tissue from biopsy, it will also be used to try to discover new
findings about how cancers respond or become resistant to cancer treatments. These
experiments will include trying to grow the cancer cells in a petri dish in the lab or
trying to grow the cancer cells inside research mice to learn more about how the cancer
works. This portion of the testing os part of the research study and is considered
experimental, so the results will not be entered into the participants' medical record.

Inclusion Criteria:

1. Patients must already be known to have metastatic, incurable cancer.

2. Patients must have been referred for repeat tumor biopsy as part of standard care and
biopsy must have been approved by the appropriate biopsy service (interventional
radiology or surgery). Such approval includes review of medical history and laboratory
parameters as per standard care.

3. 18 years of age or older

4. Patients must have previously responded to a molecularly-targeted therapy and
subsequently developed resistance, or have an analogous clinical situation in which
determining their molecular genotype is of interest clinically and/or scientifically.

No specific exclusion criteria.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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