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Biopsies of Cancer Patients for Tumor Molecular Characterization

18 Years
Open (Enrolling)
Cancer, Metastatic Cancer

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Trial Information

Biopsies of Cancer Patients for Tumor Molecular Characterization

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To determine the feasibility and safety of repeat biopsies for molecular characterization.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lecia V. Sequist, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

April 2015

Related Keywords:

  • Cancer
  • Metastatic Cancer
  • biopsy
  • tumor biopsy
  • genetic studies
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Massachusetts General Hospital Boston, Massachusetts  02114-2617