Referral Guidelines

Clinical Oncology

The clinical oncology area of interest involves clinical research designed to evaluate cancer treatment. This category includes all Phase 0, I, II and III clinical trials using drugs and biological agents, including gene therapy. Preclinical studies that address specific issues related to the design of a clinical trial may be included in this category, but should not be the objective of the grant application.

• Studies conducted with the intent of selecting patients for therapy and predicting response to specific therapies:
  • Pharmacology of drug synergism and multi-agent therapy
  • Predictability, reversibility and mechanisms of drug-induced toxicity in vitro and/or in vivo test systems to access efficacy of therapy

• Clinical studies utilizing gene therapy, gene silencing and gene marking for tracking disease recurrence
• Chemotherapy alone or in combination with radiotherapy or surgery
• Clinical studies involving:
  • In vitro or in vivo tests performed to predict clinical response to cytotoxic and biologic therapies
  • Pharmacologic and/or immunologic monitoring of the agents (plasma and/or tissue)
  • Modulation of drug toxicity and/or efficacy through chrono-therapy
  • Use of therapeutic agents to reverse resistance to or reduce toxicity from cytotoxic chemotherapy
  • Use of target specific delivery systems to enhance the selectivity and therapuetic effects of these agents
  • Establishment of dose response relationship and efficacy

• Studies conducted with the intent of selecting patients for therapy and predicting response to the specific therapies:
  • Pharmacology of drug synergism and multi-agent therapy
  • Predictability, reversibility and mechanisms of drug-induced toxicity in vitro and/or in vivo test systems to access efficacy of therapy
  • Assessment of drug resistance in human tumors; reversal of clinical drug resistance
  • Assessment of prognostic factors (biological or molecular) that may predict response to specific treatment therapies

• Clinical studies to reduce the toxicity of cytotoxic therapies by the use of agents such as:
  • Colony stimulating factors
  • Radio/chemoprotective agents
  • Agents that bind free radicals

• Clinical studies utilizing gene therapy and gene marking for tracking disease recurrence
• All types of stem cell and bone marrow transplantation in cancer patients
• Clinical studies using biological response modifiers or biological approaches to cancer treatment such as vaccines, immunotherapy, cellular therapy, antisense therapy and the use of liposomes
• Clinical studies using agents directed at subcellular target sites including cell cycle targets, oncogenes and suppressor genes
• Clinical investigation, including experimental design, computer programming and biostatistics, radiological, histopathological and immunological support
• Supportive care programs emphasizing preclinical and quality of life through supportive management of cancer patients undergoing anti-neoplastic treatment(s)
• Ethical issues in human subject research as it relates to clinical trial participation, such as informed consent, data and safety monitoring, enrollment/accrual of participants, inclusion of children, and research oversight

Surgical Oncology

• Interventional studies in which surgery is the dominant feature to prevent, diagnose, stage, or treat cancer; all surgical specialties, except neurosurgery and eye surgery, are included
• Novel infusion/perfusion devices for use with biological or chemotherapeutic agents
• Development and improvement of instruments for detection or diagnosis of tumors where surgery/biopsies is the dominant feature process
• Novel or improved surgical techniques aimed to significantly increase or enhance outcomes in cancer treatment

Cancer and Nutrition

• Nutritional assessment of the patient diagnosed with cancer
• Methods involving monitoring, assessing and validating nutritional status and changes in cancer patients
• Clinical relevance and comparison of nutritional parameters
• Special assessment problems unique to cancer population
• Body composition studies
• Anthropometrics and other physical methods
• Nutrient intake data pertaining to clinical trials involving cancer patients
• Treatment effects on assessment parameter(s) or techniques
• Obesity and its effect on clinical trial participation and cancer treatment