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ASPREE Cancer Endpoints Study (ACES)

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ClinicalTrials.gov Identifier: NCT01968798
Recruitment Status : Active, not recruiting
First Posted : October 24, 2013
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Aspirin Drug: Placebo Phase 4

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.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aspirin
100 mg enteric-coated aspirin
 Drug: Aspirin
100mg enteric-coated aspirin, taken daily
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
100mg enteric-coated placebo, taken daily


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

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


  Show 40 Study Locations
Sponsors and Collaborators
Hennepin Healthcare Research Institute.
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
Investigators
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Principal Investigator: Anne Murray, MD, MSc Berman Center
More Information
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Additional Information:
Public ASPREE website  This link exits the ClinicalTrials.gov site

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Responsible Party: Hennepin Healthcare Research Institute.
ClinicalTrials.gov Identifier: NCT01968798     History of Changes
Other Study ID Numbers: 3U01AG029824-02S1 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Keywords provided by Hennepin Healthcare Research Institute.:
ACES
ASPREE Cancer Endpoints Study
Cancer
Aspirin
Tumor
Additional relevant MeSH terms:
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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