ASPREE Cancer Endpoints Study (ACES)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Aspirin; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 14500
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham
  • California
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Howard University
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida Department of Aging and Geriatrics
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
    • Atlanta, Georgia, United States, 30322
      • Emory/ Atlanta VAMC
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Alzheimer's Disease Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Kansas City, Kansas, United States, 66106
      • Kansas University Medical Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
    • Baton Rouge, Louisiana, United States, 70801
      • Baton Rouge General
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Our Lady of the Lake Cancer Center
    • Covington, Louisiana, United States, 70433
      • Mary Bird Perkins St. Tammany Parish Hospital
    • Houma, Louisiana, United States, 70360
      • Mary Bird Perkins Terrebonne General Hospital
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
    • New Orleans, Louisiana, United States, 70112
      • LSU Health Sciences- New Orleans
    • Shreveport, Louisiana, United States, 71130
      • LSU Health Sciences- Shreveport
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48201
      • Wayne State University
    • Novi, Michigan, United States, 48377
      • Detroit Clinical Research Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55425
      • HealthPartners Research Institute
    • Saint Paul, Minnesota, United States, 55106
      • Phalen Village Clinic
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • Central Jersey Medical Center
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical College
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • Queens, New York, United States, 11432
      • Queens Cancer Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Wake Forest University Baptist Medical Center
    • Greenville, North Carolina, United States, 27834
      • The Brody School of Medicine at ECU
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh Health Sciences Research Center
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • University of Tennessee Health Science Center
    • Nashville, Tennessee, United States, 57208
      • Meharry Medical College
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center at Dallas
    • Galveston, Texas, United States, 77555
      • University of TX Medical Branch
    • Harlingen, Texas, United States, 78550
      • Regional Academic Health Center
    • San Antonio, Texas, United States, 78229
      • UT Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; 100mg enteric-coated placebo, taken daily
ACTIVE_COMPARATOR: Aspirin; 100 mg enteric-coated aspirin	Drug: Aspirin; 100mg enteric-coated aspirin, taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	every 6 months

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: National Health and Medical Research Council, Australia; National Cancer Institute (NCI); Bayer; National Institute on Aging (NIA); Monash University; Berman Center for Outcomes and Clinical Research
• Investigators: Principal Investigator: Anne Murray, MD, MSc, Berman Center

Publications and helpful links

Helpful Links

• Public ASPREE website

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (ESTIMATE): October 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Aspirin; Cancer; Tumor; ACES; ASPREE Cancer Endpoints Study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 3U01AG029824-02S1 (NIH)