ACES: ASPREE Cancer Endpoints Study

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Aspirin Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

ASPREE Cancer Endpoints Study

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin 100 mg enteric-coated aspirin	Drug: Aspirin 100mg enteric-coated aspirin, taken daily
Placebo Comparator: Placebo Placebo	Drug: Placebo 100mg enteric-coated placebo, taken daily

Arm

Intervention/Treatment

Active Comparator: Aspirin

100 mg enteric-coated aspirin

Drug: Aspirin

100mg enteric-coated aspirin, taken daily

Placebo Comparator: Placebo

Placebo

Drug: Placebo

100mg enteric-coated placebo, taken daily

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Open Only to Participants in Parent ASPREE study

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.
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.

Disability, defined as dependence in one or more Katz activity of daily living.
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.
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:

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.
Collection of cancer tumor specimens and storage and data for future use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Palo Alto Medical Foundation Research Institute	Palo Alto	California	United States	94301
3	Howard University	Washington	District of Columbia	United States	20060
4	University of Florida Department of Aging and Geriatrics	Gainesville	Florida	United States	32611
5	Morehouse School of Medicine	Atlanta	Georgia	United States	30310
6	Emory/ Atlanta VAMC	Atlanta	Georgia	United States	30322
7	Georgia Health Sciences University	Augusta	Georgia	United States	30912
8	Rush Alzheimer's Disease Center	Chicago	Illinois	United States	60612
9	University of Iowa	Iowa City	Iowa	United States	52242
10	Kansas University Medical Center	Kansas City	Kansas	United States	66106
11	Baton Rouge General	Baton Rouge	Louisiana	United States	70801
12	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808
13	Mary Bird Perkins Our Lady of the Lake Cancer Center	Baton Rouge	Louisiana	United States	70809
14	Mary Bird Perkins St. Tammany Parish Hospital	Covington	Louisiana	United States	70433
15	Mary Bird Perkins Terrebonne General Hospital	Houma	Louisiana	United States	70360
16	LSU Health Sciences- New Orleans	New Orleans	Louisiana	United States	70112
17	Tulane Medical Center	New Orleans	Louisiana	United States	70112
18	LSU Health Sciences- Shreveport	Shreveport	Louisiana	United States	71130
19	University of Michigan	Ann Arbor	Michigan	United States	48109
20	Wayne State University	Detroit	Michigan	United States	48201
21	Henry Ford Health System	Detroit	Michigan	United States	48202
22	Detroit Clinical Research Center	Novi	Michigan	United States	48377
23	HealthPartners Research Institute	Minneapolis	Minnesota	United States	55425
24	Phalen Village Clinic	Saint Paul	Minnesota	United States	55106
25	Central Jersey Medical Center	Elizabeth	New Jersey	United States	07202
26	New Jersey Medical College	Newark	New Jersey	United States	07103
27	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
28	Winthrop University Hospital	Mineola	New York	United States	11501
29	Queens Cancer Medical Center	Queens	New York	United States	11432
30	Wake Forest University Baptist Medical Center	Greensboro	North Carolina	United States	27408
31	The Brody School of Medicine at ECU	Greenville	North Carolina	United States	27834
32	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
33	University of Pittsburgh Health Sciences Research Center	Pittsburgh	Pennsylvania	United States	15260
34	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island	United States	02860
35	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38105
36	Meharry Medical College	Nashville	Tennessee	United States	57208
37	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390
38	University of TX Medical Branch	Galveston	Texas	United States	77555
39	Regional Academic Health Center	Harlingen	Texas	United States	78550
40	UT Health Science Center at San Antonio	San Antonio	Texas	United States	78229