Clinical trial NCT01968798: ASPREE Cancer Endpoints Study
Official title: ASPREE Cancer Endpoints Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cancer
Keywords: ACES
ASPREE Cancer Endpoints Study
Cancer
Aspirin
Tumor
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Aging (NIA)
name: Monash University
name: Berman Center for Outcomes and Clinical Research
name: National Health and Medical Research Council, Australia
name: Bayer
First posted: 2013-10-24
Enrollment: 14500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: every 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Department of Aging and Geriatrics
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory/ Atlanta VAMC
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Baton Rouge General
state: Louisiana
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Our Lady of the Lake Cancer Center
state: Louisiana
city: Covington
country: United States
facility: Mary Bird Perkins St. Tammany Parish Hospital
state: Louisiana
city: Houma
country: United States
facility: Mary Bird Perkins Terrebonne General Hospital
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Sciences- New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences- Shreveport
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Novi
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: HealthPartners Research Institute
state: Minnesota
city: Saint Paul
country: United States
facility: Phalen Village Clinic
state: Minnesota
city: Elizabeth
country: United States
facility: Central Jersey Medical Center
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical College
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Queens
country: United States
facility: Queens Cancer Medical Center
state: New York
city: Greensboro
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Greenville
country: United States
facility: The Brody School of Medicine at ECU
state: North Carolina
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Health Sciences Research Center
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Galveston
country: United States
facility: University of TX Medical Branch
state: Texas
city: Harlingen
country: United States
facility: Regional Academic Health Center
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Berman Center
name: Anne Murray, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: