March 3, 2014

Clinical Trial Assesses Next-Generation Cancer Genomic Test

Search for cancer-related genes is meant to improve patients’ clinical outcomes


Nearly every major hospital or cancer treatment practice performs specific genomic testing on every cancer patient’s tumor sample. Examples include KRAS oncogene analysis for those with colorectal cancer, or HER2 analysis in breast cancer. These standard-of-care tests detect a single genetic mutation associated with a patient’s tumor type.


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Since August 2013, oncologists at Cleveland Clinic have been enrolling patients in an expanded genomic testing clinical study. By the end of 2014, 250 patients with a variety of 15 different tumor types will have their tumor sample analyzed for 236 cancer-related genes as part of the investigation.

The genes tested have been implicated in cancer, with ramifications for cancer therapeutics. They all are included in the FoundationOne™ genomics assessment test. For this clinical investigation, Cleveland Clinic has partnered with FoundationOne’s developer, Foundation Medicine, a molecular information company specializing in comprehensive genomic analysis of tumors.

Broad-based Analysis

In the study, each patient’s tumor sample is tested with the FoundationOne genomics profile, which detects several types of DNA alterations — base substitutions, small insertions/deletions, copy number alterations and gene rearrangements. The test includes those genes that show a high frequency of common alterations, but also those on a tail on the curve, such as those mutations occurring at low frequency but across many different tumor types. This sort of approach provides a strong rationale for looking broadly, rather than just looking with disease-specific genes.

“We have chosen a variety of cancers that includes the most common cancers,” says Davendra Sohal, MD, MPH, staff physician in the Department of Solid Tumor Oncology and the study’s principal investigator. “The goal is to see if this type of expanded genomic testing can impact clinical outcomes in a meaningful way.”


“We understand the importance of genomic testing in a broad fashion and are investing heavily in this,” adds Brian J. Bolwell, MD, FACP, who chairs the Taussig Cancer Institute.

The study’s target population includes patients lacking good treatment options, such as those with metastatic disease or whose cancer has progressed despite one or two rounds of standard chemotherapy. “There is an opportunity to make a difference for these people if we can apply the existing knowledge about cancer mutations to making useful treatment decisions,” Dr. Bolwell says.

Feasibility and Utility

One of the trial’s goals is to study the feasibility of doing genomic analyses in everyday conditions. “We want to see how well tests like FoundationOne can be performed in a real-world setting in a variety of tumors,” says Dr. Sohal. Questions to be answered include:

  • How long does it take for a patient to be consented to receive this testing?
  • How long does it take to process the test and for doctors to get the result?
  • How long does it take for the patient to learn the result and get recommendations for treatment?

The ultimate goal is to probe the clinical usefulness of expanded genomic testing. Every test result includes molecular details about a patient’s tumor, along with supporting data suggesting a particular targeted therapy.


This information is provided to a panel of oncologists who make up the Genomics Tumor Board. The board meets weekly to review each result independently and make recommendations for treatment — whether with approved drugs or as part of clinical trials in and around Cleveland. The recommendations are transmitted to the primary oncologist, who makes final recommendations to the patient.

“If many patients can get to useful treatments — whether approved by the Food and Drug Administration, off-label, or under a clinical trial of a targeted therapy — then it can make a real difference,” says Dr. Sohal.

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