ASPREE Cancer Endpoints Study

NCT ID: NCT01968798

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

14500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin

100 mg enteric-coated aspirin

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

100mg enteric-coated aspirin, taken daily

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100mg enteric-coated placebo, taken daily

Interventions

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Aspirin

100mg enteric-coated aspirin, taken daily

Intervention Type DRUG

Placebo

100mg enteric-coated placebo, taken daily

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role collaborator

Berman Center for Outcomes and Clinical Research

OTHER

Sponsor Role collaborator

National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Murray, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Berman Center

Locations

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The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Palo Alto Medical Foundation Research Institute

Palo Alto, California, United States

Site Status

Howard University

Washington D.C., District of Columbia, United States

Site Status

University of Florida Department of Aging and Geriatrics

Gainesville, Florida, United States

Site Status

Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status

Emory/ Atlanta VAMC

Atlanta, Georgia, United States

Site Status

Georgia Health Sciences University

Augusta, Georgia, United States

Site Status

Rush Alzheimer's Disease Center

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Baton Rouge General

Baton Rouge, Louisiana, United States

Site Status

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Our Lady of the Lake Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins St. Tammany Parish Hospital

Covington, Louisiana, United States

Site Status

Mary Bird Perkins Terrebonne General Hospital

Houma, Louisiana, United States

Site Status

LSU Health Sciences- New Orleans

New Orleans, Louisiana, United States

Site Status

Tulane Medical Center

New Orleans, Louisiana, United States

Site Status

LSU Health Sciences- Shreveport

Shreveport, Louisiana, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Detroit Clinical Research Center

Novi, Michigan, United States

Site Status

HealthPartners Research Institute

Minneapolis, Minnesota, United States

Site Status

Phalen Village Clinic

Saint Paul, Minnesota, United States

Site Status

Central Jersey Medical Center

Elizabeth, New Jersey, United States

Site Status

New Jersey Medical College

Newark, New Jersey, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

Queens Cancer Medical Center

Queens, New York, United States

Site Status

Wake Forest University Baptist Medical Center

Greensboro, North Carolina, United States

Site Status

The Brody School of Medicine at ECU

Greenville, North Carolina, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Health Sciences Research Center

Pittsburgh, Pennsylvania, United States

Site Status

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Meharry Medical College

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of TX Medical Branch

Galveston, Texas, United States

Site Status

Regional Academic Health Center

Harlingen, Texas, United States

Site Status

UT Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.aspree.org

Public ASPREE website

Other Identifiers

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3U01AG029824-02S1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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