ASPREE Cancer Endpoints Study

NCT01968798 | Unknown Phase 4 DMC

• 1 other identifier: 3U01AG029824-02S1
• Study Type: interventional
• Target: 14,500
• Locations: 1 country
• Sites: 40

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.

Conditions

Cancer

Keywords

ACES; ASPREE Cancer Endpoints Study; Cancer; Aspirin; Tumor

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

100 mg enteric-coated aspirin

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Aspirin DRUG

100mg enteric-coated aspirin, taken daily

Aspirin

Placebo DRUG

100mg enteric-coated placebo, taken daily

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Aging (NIA): collaborator
• Monash University: collaborator
• Berman Center for Outcomes and Clinical Research: collaborator
• National Health and Medical Research Council, Australia: collaborator
• Bayer: collaborator

Study Sites (40)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

University of Florida Department of Aging and Geriatrics

Gainesville, Florida, 32611, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Emory/ Atlanta VAMC

Atlanta, Georgia, 30322, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66106, United States

Location

Baton Rouge General

Baton Rouge, Louisiana, 70801, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Mary Bird Perkins Our Lady of the Lake Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Mary Bird Perkins St. Tammany Parish Hospital

Covington, Louisiana, 70433, United States

Location

Mary Bird Perkins Terrebonne General Hospital

Houma, Louisiana, 70360, United States

Location

LSU Health Sciences- New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

LSU Health Sciences- Shreveport

Shreveport, Louisiana, 71130, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Detroit Clinical Research Center

Novi, Michigan, 48377, United States

Location

HealthPartners Research Institute

Minneapolis, Minnesota, 55425, United States

Location

Phalen Village Clinic

Saint Paul, Minnesota, 55106, United States

Location

Central Jersey Medical Center

Elizabeth, New Jersey, 07202, United States

Location

New Jersey Medical College

Newark, New Jersey, 07103, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Queens Cancer Medical Center

Queens, New York, 11432, United States

Location

Wake Forest University Baptist Medical Center

Greensboro, North Carolina, 27408, United States

Location

The Brody School of Medicine at ECU

Greenville, North Carolina, 27834, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Health Sciences Research Center

Pittsburgh, Pennsylvania, 15260, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

Meharry Medical College

Nashville, Tennessee, 57208, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

University of TX Medical Branch

Galveston, Texas, 77555, United States

Location

Regional Academic Health Center

Harlingen, Texas, 78550, United States

Location

UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

• Public ASPREE website

MeSH Terms

Conditions

Neoplasms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anne Murray, MD, MSc

  Berman Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 24, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: April 1, 2024
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (40)