ASPREE Cancer Endpoints Study (ACES)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01968798 |
Recruitment Status :
Active, not recruiting
First Posted : October 24, 2013
Last Update Posted : April 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Drug: Aspirin Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 14500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | ASPREE Cancer Endpoints Study |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | April 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Aspirin
100 mg enteric-coated aspirin
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Drug: Aspirin
100mg enteric-coated aspirin, taken daily |
Placebo Comparator: Placebo
Placebo
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Drug: Placebo
100mg enteric-coated placebo, taken daily |
- 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. [ Time Frame: 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.

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Open Only to Participants in Parent ASPREE study
- 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.
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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).
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968798

Principal Investigator: | Anne Murray, MD, MSc | Berman Center |
Responsible Party: | Hennepin Healthcare Research Institute |
ClinicalTrials.gov Identifier: | NCT01968798 |
Other Study ID Numbers: |
3U01AG029824-02S1 ( U.S. NIH Grant/Contract ) |
First Posted: | October 24, 2013 Key Record Dates |
Last Update Posted: | April 5, 2021 |
Last Verified: | April 2021 |
ACES ASPREE Cancer Endpoints Study Cancer Aspirin Tumor |
Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |