Cancer
Conditions
Keywords
ACES, ASPREE Cancer Endpoints Study, Cancer, Aspirin, Tumor
Brief summary
The ASPREE Cancer Endpoint Study (ACES), an ancillary study of the ASPirin in the Prevention of Events in the Elderly (ASPREE) Study, will allow for the examination of the effect of daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected specific incident and recurrent cancer and metastases. The establishment of this ACES biobank will allow for the exploration of DNA-related molecular mechanisms of aspirin's protective effect against cancer, cancer associated mortality and metastases, using blood or saliva DNA specimens, urine, and tumor tissue.
Detailed description
The ASPREE Cancer Endpoint Study (ACES) is an ancillary study of the ASPirin in the Prevention of Events in the Elderly (ASPREE) Study, a 5 year randomized placebo- controlled trial of 100 mg of daily aspirin in 19,000 elderly in Australia and the US to determine whether the benefits of low dose daily aspirin outweigh the bleeding risks. The primary outcome of ASPREE is defined as prolongation of disability-free life, measured as survival without physical disability or dementia. At present, the primary purpose of ACES is to: 1) collect information about participant cancer screenings, cancer diagnosis, and family history of cancer and to 2) establish a biologic specimen repository (biobank) for DNA and tumor tissue, and urine from the ASPREE large healthy aging population in the US and Australia for future use by ASPREE, NIA and NCI investigators, and academicians from the broader research community. At a time in the future and under separate application, the stored blood or saliva, urine, and tumor tissue, together with other information obtained about these participants (in relation to their health, lifestyle and other circumstances) will be analyzed to address specific questions regarding the association of biomarkers and major health outcomes including cancer.
Interventions
DRUGAspirin
100mg enteric-coated aspirin, taken daily
DRUGPlacebo
100mg enteric-coated placebo, taken daily
Sponsors
National Cancer Institute (NCI)
National Institute on Aging (NIA)
Monash University
Berman Center for Outcomes and Clinical Research
National Health and Medical Research Council, Australia
Bayer
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Open Only to Participants in Parent ASPREE study 1. Inclusion criteria: Men and women 65 years and older in US (African American or Hispanic), and 70 years of age and over in Australia (Caucasian, Asian, other minorities). Based on NIAs discretion, select US sites may be recruiting Caucasians 70 and older or 75 and older. 2.
Exclusion criteria
(please see www.ASPREE.org for more detailed list of
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To examine the effect of daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected specific incident and recurrent cancer and metastases. | every 6 months | The ASPREE Cancer Endpoint Study (ACES) will allow for the examination of the effect of daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected specific incident and recurrent cancer and metastases. The establishment of this ACES biobank will allow for the exploration of DNA-related molecular mechanisms of aspirin's protective effect against cancer, cancer associated mortality and metastases, using blood or saliva DNA specimens, urine, and tumor tissue. |
Countries
United States
Outcome results
None listed