ROCKVILLE, Maryland—The emerging science of protein analysis called proteomics is being applied directly to the care of cancer patients in a joint research and clinical program of the Food and Drug Administration (FDA) and the National Cancer Institute (NCI). Proteomics is the study of the body’s proteins and how they function and interact.

The two federal agencies began a research collaboration on proteomics in 1997 headed by Emanuel Petricoin, PhD, of the FDA and Lance Liotta, MD, PhD, of the NCI. The two scientists will also lead the new 3-year, $3.3 million collaborative Clinical Proteomics Program.

Potential Benefits of the Clinical Proteomics Program Developing individualized therapies using targeted treatments that have been predetermined to be effective for each patient. Determining the toxic and beneficial effects of treatments first in the laboratory before using them on patients. Diagnosing cancer earlier than is now possible. Improving the understanding of tumors at the protein level, leading to better treatments.

In the course of their 4-year collaboration, the two researchers and their co-workers have developed new technologies for determining the protein "fingerprints" of cells that may warn of early side effects of drugs. They have also invented or refined several important technologies for analyzing proteins.

Drs. Petricoin and Liotta have identified more than 130 proteins that change in concentration as breast, ovary, prostate, or esophageal cells grow abnormally and then become cancerous. These protein changes may one day provide ways to diagnose and treat cancer very early or, perhaps, begin preventive therapy.

"The great challenge now in proteomics research is to begin to apply these technologies to clinical care," Dr. Petricoin said. "We hope to take these techniques out of the lab to assess their benefit for people with cancer, in a true bench-to-bedside clinical research program." NCI has recently begun clinical trials using proteomics to help make decisions about the course of patients’ experimental treatments.

In the new program, cells are extracted from cancer patients at the NIH’s Clinical Research Center using a microscope, invented in Dr. Liotta’s lab, that enables researchers to isolate pure normal, precancerous, and tumor cells from the same patient. By capturing cells directly from the tissue, the original protein pattern of the cells is maintained, which is not the case with traditional isolation methods.

After the patient has been treated, the scientists analyze the protein patterns in the extracted tumor cells. Thus, the group hopes to answer such questions as how a specific treatment changes the patterns of proteins within cells and whether the protein patterns change if a tumor recurs following treatment.