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NCT01968798 Clinical Trial

ASPREE Cancer Endpoints Study

Cancer Clinical Trial

— ACES  

Official title:
ASPREE Cancer Endpoints Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01968798
Other study ID # 3U01AG029824-02S1
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date September 2013
Est. completion date April 2024

Study information
Verified date April 2021
Source Hennepin Healthcare Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 14500
Est. completion date April 2024
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aspirin
100mg enteric-coated aspirin, taken daily
• Placebo
100mg enteric-coated placebo, taken daily

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Emory/ Atlanta VAMC Atlanta Georgia
United States Morehouse School of Medicine Atlanta Georgia
United States Georgia Health Sciences University Augusta Georgia
United States Baton Rouge General Baton Rouge Louisiana
United States Mary Bird Perkins Our Lady of the Lake Cancer Center Baton Rouge Louisiana
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States The University of Alabama at Birmingham Birmingham Alabama
United States SUNY Downstate Medical Center Brooklyn New York
United States Rush Alzheimer's Disease Center Chicago Illinois
United States Mary Bird Perkins St. Tammany Parish Hospital Covington Louisiana
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States Wayne State University Detroit Michigan
United States Central Jersey Medical Center Elizabeth New Jersey
United States University of Florida Department of Aging and Geriatrics Gainesville Florida
United States University of TX Medical Branch Galveston Texas
United States Wake Forest University Baptist Medical Center Greensboro North Carolina
United States The Brody School of Medicine at ECU Greenville North Carolina
United States Regional Academic Health Center Harlingen Texas
United States Mary Bird Perkins Terrebonne General Hospital Houma Louisiana
United States University of Iowa Iowa City Iowa
United States Kansas University Medical Center Kansas City Kansas
United States University of Tennessee Health Science Center Memphis Tennessee
United States Winthrop University Hospital Mineola New York
United States HealthPartners Research Institute Minneapolis Minnesota
United States Meharry Medical College Nashville Tennessee
United States LSU Health Sciences- New Orleans New Orleans Louisiana
United States Tulane Medical Center New Orleans Louisiana
United States New Jersey Medical College Newark New Jersey
United States Detroit Clinical Research Center Novi Michigan
United States Palo Alto Medical Foundation Research Institute Palo Alto California
United States Memorial Hospital of Rhode Island Pawtucket Rhode Island
United States Albert Einstein Medical Center Philadelphia Pennsylvania
United States University of Pittsburgh Health Sciences Research Center Pittsburgh Pennsylvania
United States Queens Cancer Medical Center Queens New York
United States Phalen Village Clinic Saint Paul Minnesota
United States UT Health Science Center at San Antonio San Antonio Texas
United States LSU Health Sciences- Shreveport Shreveport Louisiana
United States Howard University Washington District of Columbia

Sponsors (7)
Lead Sponsor Collaborator
Hennepin Healthcare Research Institute Bayer, Berman Center for Outcomes and Clinical Research, Monash University, National Cancer Institute (NCI), National Health and Medical Research Council, Australia, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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