ASPREE Cancer Endpoints Study

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.

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 exclusion
criteria) i. History of diagnosed dementia or score < 78 on the Modified Mini Mental
State Exam at the second pre-randomization (baseline) visit.

ii. Disability, defined as dependence in one or more Katz activity of daily living.

iii. Cardiovascular events, intercurrent illness likely to cause death within the next
5 years, a current or recurrent condition with a high risk of major bleeding, e.g.
cerebral aneurysm, cerebral AV malformation, any bleeding diathesis, recent peptic
ulcer and liver disease.

iv. Anemia, i.e. hemoglobin level below the normal value (males: 12 g/dL, females: 11
g/dL).

3. Participants eligible for the ASPREE Cancer Endpoints Study (ACES) include any
participants recruited into the parent ASPREE study in the United States and
Australia. ACES participants will be asked to consent to:

i. Collection and storage of blood or saliva DNA samples and urine and data for future use.
If ASPREE participants are unwilling to contribute biological samples, this will not in any
way jeopardize their continued enrolment in ASPREE.

ii. Collection of cancer tumor specimens and storage and data for future use.