Last Updated: 04/06/07
Program for the Assessment of Clinical Cancer Trials
Website: http://www.cancerdiagnosis.nci.nih.gov/assessment/index.html
Contact:
Sheila E. Taube, Ph.D.
301-496-8639, st29f@nih.gov
Many decisions relating to cancer patient management depend on information derived from clinical laboratory tests. Significant research and development are involved in producing a test that is reliable enough for routine clinical use. CDP launched the Program for the Assessment of Clinical Cancer Tests (PACCT) in 2000 to develop a process for moving the advances in new technologies and new understanding of cancer biology more efficiently and effectively into clinical practice.
A primary goal of PACCT is to develop more informative laboratory tools to help maximize the impact of cancer treatments. PACCT focuses on developing tests for cancer diagnosis, prognosis, and prediction of response to therapy. Its activities also include the generation of reference sets of clinical specimens, which are available to academic and industry researchers working to evaluate new markers and validate the utility of some known markers and tests.
PACCT is guided by a multidisciplinary strategy group, which developed criteria for assessing which markers are ready for further development. The strategy group comprises scientists from academia, as well as Food and Drug Administration (FDA) and NCI staff with expertise in clinical oncology, pathology, basic cancer biology, diagnostics technology and assay development, clinical trials methodology, and statistics.
The strategy group establishes working groups to address critical clinical problems in specific tumors. The Breast Cancer Working Group’s efforts have led to the Trial Assigning Individualized Options for Treatment (TAILORx), which is assessing the clinical utility of a new prognostic tool based on analysis of molecular signatures. The Colon Cancer Working Group is focusing on assay standardization and validation issues. Its goal is to validate tests to determine whether it is possible to identify a subgroup of patients with stage II colon cancer at sufficiently high risk to benefit from adjuvant chemotherapy. Working groups have recently been convened to address difficult clinical issues in prostate and lung cancer.
