NCI Clinical Trials

NCI supports the following relevant areas of research: 

CANCER PREVENTION, CONTROL AND POPULATION SCIENCES

NCI supports investigator-initiated clinical trials aimed at reducing the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and cancer survivorship.

The Division of Cancer Prevention (DCP) supports cancer prevention, detection, screening, interception, and symptom management research.

The Division of Cancer Control and Population Sciences (DCCPS) supports cancer surveillance, epidemiology, health services, behavioral science, and cancer survivorship research. 

Examples of Research Areas:

• Cancer prevention and interception: development and testing interventions (e.g.,  diet, nutritional compounds, drugs, small molecules, vaccine and biologics) and approaches (e.g.,  physical activity, medical devices, cancer preventive surgery, risk-reducing surgery, and non-surgical ablative techniques) to block, reverse, or delay early-stage cancer (including treatment of preneoplastic lesions, presurgical trials in early-stage cancer with the intent of developing an agent/intervention for cancer prevention, and . studies examining mechanisms and surrogate biomarkers of efficacy;
• Cancer screening: studies of operating characteristics and clinical impact (harms as well as benefits) of cancer early detection technologies and practices, such as imaging and molecular biomarker approaches;
• Early detection: studies for identification, development, and validation of biological markers for early cancer detection and cancer risk assessment;
• Behavioral research in cancer prevention and control: development and testing interventions addressing cancer-related health behaviors such as tobacco use, diet or nutrition, physical activity, obesity, alcohol use, sun exposure; vaccine uptake; immune function; screening; treatment adherence; and related biopsychosocial processes. This research encompasses communication, decision science, environmental and policy interventions to improve cancer-related health behaviors, risks and outcomes;
• Susceptibility to cancer and cancer-related outcomes: strategies to translate clinical, environmental and genomic/genetic determinants of cancer occurrence and outcomes into evidence-based interventions for clinical and public health practice;
• Implementation science: strategies to promote the adoption, implementation, and sustainability of evidence-based cancer interventions into routine healthcare and public health settings or the deimplementation of ineffective cancer interventions;
• Healthcare delivery: single and multi-level interventions addressing the organization and/or delivery of cancer care (e.g., team-based care; novel use of electronic health records; new organizational mechanisms/staffing such as patient navigation; new models of specialized services such as palliative care or survivorship programs);
• Cancer survivorship: interventions addressing the physical, psychological, social, and financial burden of cancer and its treatment among survivors of cancer and their families (e.g., mental health, social functioning, caregiver well-being and adaptation);
• Supportive and palliative care: development and testing interventions (e.g., diet, nutritional compounds, drugs, small molecules, vaccine and biologics) and approaches for the prevention or treatment of acute and chronic symptoms and morbidities related to cancer and its treatment including those experienced by patients with metastatic cancer; and/or
• Quality of Life (QOL): studies to improve the QOL of cancer patients.

CANCER TREATMENT AND DIAGNOSTIC RESEARCH

NCI supports investigator-initiated Phase 0, I, and II clinical trials for cancer-targeted diagnostic and therapeutic interventions. These early-stage trials aim to improve diagnosis, treatment, and quality of life for patients, leading to better outcomes, including those who may not be cured, and help reduce the impact of cancer. 

The Division of Cancer Treatment and Diagnosis (DCTD) supports research projects designed to advance cancer treatment and diagnostics through innovative therapies, improved imaging, surgical interventions, and integrated care. These clinical studies may combine investigational modalities with standard therapies and should align with the goals and interests of the specific DCTD research programs listed below: 

• Cancer Therapy Evaluation Program
• Cancer Imaging Program
• Cancer Diagnosis Program
• Radiation Research Program
• Complementary and Alternative Medicine Program

The Office of Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) Malignancies (OHAM) supports cancer treatment and diagnostic studies specifically for patients with HIV/AIDS-related malignancies. 

Examples of Research Areas:

• Evaluates the dosing, safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of novel anticancer drugs, biologics, immunotherapeutics (e.g., adoptive cell transfer therapies), and their combinations as well as imaging agents or other interventions;
• Tests approved agents and combinations for new indications;
• Evaluates new or improved image-guided interventions, radiation modalities, means of delivery, or combinations with novel agents;
• Tests imaging probes or quantitative approaches incorporated into commercially available imaging instrumentation (e.g., positron emission tomography [PET], single photon-emission computed tomography [SPECT], magnetic resonance [MR] imaging, computed tomography [CT], ultrasound [US], optical imaging, and photoacoustic imaging [PAI]);
• Assesses tools, methods, devices, and instruments that can perform at the molecular, cellular, and organ levels;
• Investigates multi-parametric imaging approaches and biomarker detection assays including radiomics, radiogenomics, genomics, proteomics, and metabolomics;
• Evaluates imaging or laboratory biomarker activity, pharmacodynamic response, target engagement, dose-response trends;
• Selects or ranks the best potential interventions, technologies, and/or dosing regimens to be evaluated in a subsequent trial, based on tolerability, safety data, biological activity, or preliminary clinical efficacy (e.g., a futility trial);
• Conducts exploratory investigational new drug (IND) and/or investigational device exemption (IDE) studies; 
• Evaluates integrative medicine approaches such as diets, nutrients, herbs, bioactive food components, pre/probiotics, microbiota practices, and mind-body interventions (e.g., acupuncture, exercise, meditation, and sleep) to improve standard of care or investigational therapeutics;
• Conducts co-clinical trials that include patients as well as parallel or sequential animal or human-in-animal models that mirror patient biology and genetics, using AI/machine learning and functional precision approaches alongside intervention studies;
• Conducts HIV and AIDS-related clinical trials utilizing the above diagnostic and therapeutic strategies for individuals with HIV/AIDS-associated malignancies.