ASPREE Cancer Endpoints Study
- Registration Number
- NCT01968798
- Lead Sponsor
- Hennepin Healthcare Research Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Aspirin Aspirin 100 mg enteric-coated aspirin
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Emory/ Atlanta VAMC
🇺🇸Atlanta, Georgia, United States
The Brody School of Medicine at ECU
🇺🇸Greenville, North Carolina, United States
New Jersey Medical College
🇺🇸Newark, New Jersey, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Rush Alzheimer's Disease Center
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Health Sciences Research Center
🇺🇸Pittsburgh, Pennsylvania, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Baton Rouge General
🇺🇸Baton Rouge, Louisiana, United States
LSU Health Sciences- New Orleans
🇺🇸New Orleans, Louisiana, United States
Mary Bird Perkins Our Lady of the Lake Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Mary Bird Perkins Terrebonne General Hospital
🇺🇸Houma, Louisiana, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
HealthPartners Research Institute
🇺🇸Minneapolis, Minnesota, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
University of Florida Department of Aging and Geriatrics
🇺🇸Gainesville, Florida, United States
Palo Alto Medical Foundation Research Institute
🇺🇸Palo Alto, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Mary Bird Perkins St. Tammany Parish Hospital
🇺🇸Covington, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Phalen Village Clinic
🇺🇸Saint Paul, Minnesota, United States
Detroit Clinical Research Center
🇺🇸Novi, Michigan, United States
Central Jersey Medical Center
🇺🇸Elizabeth, New Jersey, United States
Queens Cancer Medical Center
🇺🇸Queens, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Wake Forest University Baptist Medical Center
🇺🇸Greensboro, North Carolina, United States
University of TX Medical Branch
🇺🇸Galveston, Texas, United States
Regional Academic Health Center
🇺🇸Harlingen, Texas, United States
UT Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Georgia Health Sciences University
🇺🇸Augusta, Georgia, United States
LSU Health Sciences- Shreveport
🇺🇸Shreveport, Louisiana, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States