If you’ve received a cancer diagnosis recently, you may be surprised to learn that in many cases, treatment options have not greatly changed over the past 15 to 20 years. For many types of cancer, surgery, usually followed by radiation, chemotherapy, and/or hormone therapy, continues to represent the “standard of care”.

Personalized therapy, consisting of a treatment with an agent that targets a specific molecular alteration in the cancer, may be available for treatment in a small subset of cancers, but this depends on whether specific molecular biomarkers have been identified for the particular tumor type.

In order to broaden the reach of personalized medicine to greater numbers of cancer patients, biomedical research requires help from patients, researchers, and the pharmaceutical/biotechnology industries.

• Patients need to be provided with information that helps them understand the importance of biospecimen donation; this may then persuade them to participate and donate.
• Researchers must continue to focus on identifying meaningful cancer biomarkers.
• Stakeholders must work together to identify successful means of creating additional tissue banks to facilitate and expedite the biomarker discovery process.
• Private industry, including pharmaceutical and biotechnology companies, must continue to focus on developing targeted treatments and the molecular diagnostics needed, besides conducting clinical trials to study agents’ safety and efficacy.

For consistency in this discussion, most of the examples described will refer to solid tumors in the cancer setting. Because the term “tissue” is often used interchangeably with the term “biospecimen” and is a more familiar term, the rest of this section will refer to biospecimens as tissue.

Why tissue is needed

Cancer research would not be able to move forward without donated human tissue.

Such research plays a crucial role in addressing the full spectrum of healthcare concerns regarding cancer, including:

• Prevention
• Early detection
• Diagnosis
• Treatment

In addition, as discussed throughout this module, this research has been critical to the discovery and development of biomarkers that have already made a tremendous impact in improving the diagnosis and treatment of specific types of cancer (see section on Personalized Medicine).

In this setting, research on human tissues enables research into:

• The identification and validation of biomarkers and the creation of biomarker tests (assays) that may predict response to a particular treatment (often called companion diagnostics).
• The identification and validation of biomarkers that improve the ability to predict individual prognosis, e.g., the presence or lack of the estrogen receptor (ER) in breast cancers. Tests that are used to measure these biomarkers are referred to as “molecular diagnostics”.

Below are examples of research successes made possible by tissue donation:

Biomarkers Found	Agents Developed
BCR-ABL HER2/neu K-RAS C-kit EGFR B-RAF	Gleevec (CML) Herceptin (breast cancer) Cetuximab (colon cancer) Gleevec (GIST) Iressa (NSCLC) Zelboraf (melanoma)

For more information on these agents, please click here.

Cancer research takes place in many different types of facilities:

• Academic medical centers
• Community hospitals
• VA hospitals
• Pharmaceutical and biotechnology companies
• Government medical centers within the National Institutes of Health (NIH)
• Military biomedical research centers
• Centers of physical sciences.

Most, if not all, of these entities have a need for human tissue for research purposes, even when they do not have direct interaction with patients or research participants. Thus, it is important that people who may be able to donate tissue are fully informed about this aspect of research.