ASPREE Cancer Endpoints Study

• Status: Active, not recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hennepin Healthcare Research Institute; Minneapolis Medical Research Foundation
• Collaborators: Bayer; Berman Center for Outcomes and Clinical Research; Monash University; National Cancer Institute (NCI); National Health and Medical Research Council, Australia; National Institute on Aging (NIA)
• Treatments: Aspirin

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 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.