[CBSS Roster]

The Cancer Biomarkers Study Section reviews applications addressing the discovery, validation and development of biomarkers for risk, early detection, diagnosis, prognosis and progression of cancer.  Research on markers related to predicting treatment response, studies measuring minimal residual disease and monitoring therapeutic efficacy are also considered.  The development of bioassays for the discovery and testing of cancer markers may be assigned to CBSS.

Specific areas covered by CBSS include:

• Identification of biomarkers for disease detection, differential diagnosis, prognosis, predicting response to therapy, monitoring minimal residual disease and measuring tumor burden through analysis and/or molecular profiling of DNA, RNA, and protein from tumor tissue or body fluids.
  
  
• Validation of new biomarkers using animal models, human materials and clinical trials.
  
  
• Phase-I and phase-II clinical trials where the primary goal is marker validation.
  
  
• Phase-III trials (validation studies) of markers for determining risk, early detection or choice of therapy.
  
  
• Early detection of cancer, or monitoring its progression or response to therapy using available medical imaging approaches.
  
  
• Development of novel methods for biostatistical analysis, informatics, and modeling that facilitate the discovery, evaluation, and use of markers.

CBSS has the following shared interests within the ONC IRG:

• With Cancer Etiology [CE] in the identification and evaluation of markers that assess risk (including risks from environmental carcinogens and tumor-associated pathogens): Mechanism-driven studies could be assigned to CE; empirical studies to identify biomarkers for cancer risk and patient-oriented research to assess the clinical utility of markers could be assigned to CBSS.
  
  
• With Cancer Genetics [CG] regarding discovery and evaluation of genetic and epigenetic abnormalities in tumors that may serve as clinical biomarkers useful for establishing disease prognosis or predicting response to therapy:  When the focus is on understanding the disease process, the application could be assigned to CG; when the focus is on identification of markers for clinical applications, the proposal could be assigned to CBSS.
  
  
• With Cancer Molecular Pathobiology [CAMP]  and Tumor Cell Biology [TCB] in the discovery and evaluation of novel biological markers, signatures, patterns and signaling pathways in normal and tumor tissues:  When the focus is on understanding the disease mechanism, the study could be assigned to CAMP or TCB; when the focus is on identifications of markers for clinical application, it could be assigned to CBSS. 
  
  
• With Tumor Microenvironment [TME] and Tumor Progression and Metastasis [TPM] in the discovery and evaluation of biomarkers for angiogenesis, invasion, tissue or host response and other aspects of cancer progression that may serve as clinical biomarkers:  When the focus is on understanding disease mechanisms, the study could be assigned to TPM or TME; when the focus is on identification of biomarkers for clinical application, the study could be assigned to CBSS.
  
  
• With Chemo/Dietary Prevention [CDP] in evaluating biomarkers for chemoprevention: studies of biomarkers that relate to monitoring chemoprevention or dietary prevention could be assigned to CDP:  Studies focusing on clinical biomarker development could be assigned to CBSS.
  
  
• With Radiation Therapeutics and Biology [RTB] in the evaluation of markers that monitor trials of radiation therapy: When emphasis is on optimizing radiation therapy or on in vivo investigation of radiation response mechanisms, applications could be assigned to RTB; when the emphasis is on evaluation of markers, applications could be assigned to CBSS. 
  
  
• With Cancer Immunopathology and Immunotherapy [CII] in the development and characterization of novel targets for immunotherapy and immune response profiling:  When the focus is on assessment of the activity of new agents, the study could be assigned to CII; when the focus is on prediction of the patient's response to therapy, the study could be assigned to CBSS.
  
  
• With Developmental Therapeutics [DT] in validating molecular markers of tumor and host response:  when the focus is on assessment of the activity of new agents, the study could be assigned to DT; when the focus is on prediction of the patient's response to therapy, the study could be assigned to CBSS.
  
  
• With Clinical Oncology [CONC] in the evaluation of biomarkers that monitor trials of therapy: studies of markers for evaluating novel agents in Phase-1 and -2 trials could be assigned to CONC; retrospective correlative studies and studies of biomarkers that predict response to established therapeutic agents could be assigned to CBSS.

CBSS has the following shared interests outside the ONC IRG:

• With the Bioengineering Sciences and Technologies [BST] IRG: In general, the development of new technologies, computational methods, bioinformatics approaches and systems, and mathematical models could be assigned to BST; the application of these approaches to the study of tumor markers could be assigned to CBSS.
  
  
• With Organ-system IRGs: In general, studies of biomarkers for the early detection of tumors are shared between the organ-system IRGs and CBSS; studies of biomarkers for progression, differential diagnosis, prognosis, minimal residual disease and prediction of response to chemotherapy could be assigned to CBSS.
  
  
• With the Surgical Sciences, Biomedical Imaging and Bioengineering [SBIB] IRG: When the primary focus of a study is to evaluate the potential of novel diagnostic imaging instrumentation or to improve image acquisition or analysis, the study could be assigned to SBIB; when imaging is directed toward molecular targets for early detection, prognosis, progression or response to cancer therapy, the study may be assigned to CBSS.