ASPREE Cancer Endpoints Study



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:12/21/2018
Start Date:September 2013
End Date:January 2019

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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.

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.

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.
We found this trial at
40
sites
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
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Atlanta, Georgia
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1459 Laney-Walker Blvd
Augusta, Georgia 30901
(706) 721-3052
Georgia Health Sciences University Georgia Regents University, home of the Medical College of Georgia, is...
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Baton Rouge, Louisiana 70801
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Chicago, Illinois 60612
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Covington, LA
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Detroit, Michigan 48202
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Elizabeth, New Jersey 07202
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2004 Mowry Road
Gainesville, Florida 32611
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Galveston, Texas 77555
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Greensboro, North Carolina 27408
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Greenville, North Carolina 27834
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Harlingen, Texas 78550
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Houma, LA
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Kansas City, Kansas
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Minneapolis, Minnesota 55425
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Nashville, Tennessee 37208
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New Orleans, Louisiana 70112
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New Orleans, Louisiana 70112
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Newark, New Jersey 07103
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Novi, Michigan 48337
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111 Brewster St
Pawtucket, Rhode Island 02860
(401) 729-2000
Memorial Hospital of Rhode Island Memorial Hospital of Rhode Island is a 294-bed community teaching...
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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Queens, New York 11432
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1414 Maryland Avenue East
Saint Paul, Minnesota 55106
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San Antonio, Texas 78229
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Shreveport, Louisiana 71130
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Washington, District of Columbia 20060
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