New Study Designs

The Division of Cancer Prevention is expanding clinical research beyond standard trial designs to find interventions that may play a role in more than one prevalent disease.

Using Non-Cancer Trials to Find Cancer Prevention Signals

Diabetes Prevention Program Outcome Study (DPPOS) Collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NCI is looking at this cohort study to examine if metformin or lifestyle intervention used to prevent development of diabetes in a population at risk of the disease, can also modify cancer incidence, especially in obesity-related cancers (breast, colon & rectum, endometrium, pancreas, esophagus, gall bladder, and kidney).

Aspirin in Reducing Events in Elderly (ASPREE) Study Collaboration with the National Institute on Aging (NIA)

Aspirin in Reducing Events in the Elderly (ASPREE) is a Phase III double-blind, randomized, placebo-controlled primary prevention trial designed to assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy participants aged 70 years, and aged 65 and above for Hispanic and African Americans in the USA. The study is examining whether the potential benefits of low-dose aspirin outweigh the risks in this age group. At present, the use of aspirin for primary prevention is based largely on studies in middle-aged adults where the incidence of adverse effects is low. However, the risk-benefit ratio in older persons is an area of continuing controversy. The result of the ASPREE aspirin study will have the potential to alter clinical practice for the majority of the older U.S. population where approximately 60% of those over 65 are free of heart disease, stroke and mental or physical disability. Low dose aspirin (100 mg/day) reduces total cancer incidence and/or age-related cancer incidence (adenocarcinomas including colorectal, esophageal, stomach, lung, prostate etc) and cancer-associated mortality. The study will include 19,000 participants from the U.S. and Australia. NCI is funding the collection of biospecimens from this randomized trial.