Clinical Trials

Overview

Depending on your unique diagnosis, your doctor may introduce the idea of a clinical trial. It may be the best treatment option if your cancer has become resistant to the current treatment; when curative therapies are not yet available for that cancer type, subtype or stage; or the cancer is rare and has few, if any, approved treatments. Now is the time to discover what you know about clinical trials so you can be ready for the conversation if it presents itself.

What Is A Clinical Trial?

A clinical trial is a research study that tests a new medical approach. Most cancer treatments used today were once research therapies or procedures that were developed, tested and evaluated through the clinical trials process to gain approval from the U.S. Food and Drug Administration (FDA).

Many types of clinical trials exist. Some evaluate new methods for improving different areas of cancer care, including disease prevention, patient screening, diagnostic tools and procedures, genetic risk factors, and lifestyle or behavioral changes that may improve health and/or quality of life (having fewer or more manageable side effects, for example). This includes testing drugs, biologics and other non-medication therapies such as radiation therapy and surgery, medical devices, screening approaches and other interventions. Trials may also evaluate patient-reported outcomes, which are important to improving the quality of patient care.

Each trial has its own unique eligibility criteria, such as biomarker status, cancer type, subtype, stage or treatment history. Your age, gender and any additional health conditions may also be factors.

Potential Benefits

Receiving your cancer treatment through a clinical trial may offer you the following:

  • Access to state-of-the-art cancer treatment that is not available outside clinical trials.
  • Early intervention in treating side effects or addressing any complications, due to extra medical attention.
  • A role in advancing cancer research by helping to improve treatment options for future patients.

As with any cancer treatment, a clinical trial presents potential risks and side effects. It may require more medical appointments and/or tests than you would ordinarily have scheduled. Talk with your doctor about what to expect, and make sure you’ll be able to rearrange your schedules for work, school, family commitments and other obligations to accommodate the appointments required to meet the trial’s protocol.

 

Words To Know

Biomarker testing: Biomarkers are the molecules produced by cancer cells or other cells in the body in response to cancer. Biomarker testing may include testing for specific genes, proteins or molecules of the tumor and can be measured in the blood, plasma, urine, cerebrospinal fluid or other body fluids or tissues. Biomarkers are also known as tumor markers, molecular markers, biological markers or serum markers.

Biopsy: A biopsy is a procedure to collect a sample of tissue or cells to be examined under a microscope to see if cancer cells are present. Obtaining and analyzing a biopsy sample are crucial to diagnosing the type of cancer you may have because it will help your doctor determine the most effective type of treatment. A biopsy can be done by several methods depending on the cancer.

Immunotherapy: Drugs that harness the potential of the body’s immune system to recognize and destroy cancer cells. Many types are available to be used alone or with other treatments.

Microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR): These may be tested to determine whether the cancer is caused by genes that have problems repairing themselves. MSI-H describes cancer cells that have a greater than normal number of genetic markers called microsatellites, which are short, repeated sequences of DNA. Every time a cell reproduces itself, it makes a copy of its genes and DNA. During the process, errors in duplication can be made, much like a misspelled word. The body normally corrects the error, but sometimes it isn’t caught and fixed. It then becomes a mutation that is reproduced in later versions of the cell. When cells lose the ability to correct errors, it is known as deficient mismatch repair (dMMR). Cancer cells that have large numbers of microsatellites may have defects in the ability to correct mistakes that occur when DNA is copied. Cancers with MSI-H features appear to respond better to immunotherapy.

PD-L1 expression: This may be tested on tumor cells or immune cells in the tumor’s microenvironment. A higher level may mean you could be a good candidate for immune checkpoint inhibitors. Research has shown that people with a high level of PD-L1 expression sometimes respond better to immunotherapy. In addition, the level of expression will help the doctor determine whether to give immunotherapy alone or in combination with chemotherapy.

Not everyone with a high PD-L1 expression should be given immunotherapy, and not all people who receive immunotherapy respond. In some cases, people with high expressions do not respond to immunotherapy. Some people with a low PD-L1 expression do respond but less often.

Targeted therapy: A type of treatment that uses drugs or other substances to identify and attack specific types of cancer cell with less harm to normal cells.

Tumor markers: These are tested for during diagnosis and treatment to look for molecules that are produced by cancer cells or other cells in the body in response to cancer. Blood or tissue from the tumor may be used.

 

 

 

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