Peter Lance, MD, ACP Principal Investigator, Arizona Cancer Center, University of Arizona

Colorectal cancer is one of the leading causes of death in the United States. Adenomatous polyps of the colon and rectum are benign but may eventually turn into cancer. The Adenomatous Colorectal Polyps (ACP) study was designed to evaluate the effects of the SELECT supplements on the occurrence of colorectal polyps. Polyps are detected by colorectal screening procedures such as colonoscopy and sigmoidoscopy.

The ACP study is interested in all colon screening procedures since participants started on SELECT. Therefore, we continue to enroll eligible participants during this transition period and collect a signed medical release form for all eligible procedures. If you've had one of these procedures since you started on SELECT, indicate this on your study questionnaires. It will help us identify who is potentially eligible for the ACP study. We are interested in all colorectal screening procedures, even if they were done after you stopped taking study supplements. These screening procedures are valuable to our study analysis.

If you agree to participate in SELECT Centralized Follow-up, you will answer questions about colon screening procedures on your Annual Booklets. If you report a screening procedure, the SELECT Coordinating Center will contact you to sign a consent and to complete a medical release form. All participants, regardless of which Study Supplements they were taking, can be a part of ACP if they participate in SELECT Centralized Followup and report a colorectal screening procedure. By obtaining information on colon screening procedures from participants in SELECT Centralized Follow-up, we will reach our goal of registering 8,000 SELECT participants to the ACP study!

When enough participants have agreed to take part in the ACP study, and we've collected and reviewed all colon screening procedure reports, we will begin to analyze the information. Once we have verified all of the information collected, and the investigators have studied the findings, we will inform participants of the results of the study.

 

The PREADVISE Investigators and Staff, Sanders-Brown Center on Aging, University of Kentucky

The investigators at the University of Kentucky wish to thank all of our 7,000+ participants who enrolled in PREADVISE (Prevention of Alzheimer's Disease with Vitamin E and Selenium). At your last in-person visit at your study site, you may have been asked to consent to continue your participation in PREADVISE. If you agree to continue, you will be giving us permission to contact you each year by telephone to complete your memory and thinking screenings. So far, nearly half of our participants have consented to telephone follow-up. The more participants who elect to continue, the stronger our conclusions will become.

As you may recall, we are studying antioxidants as a prevention mechanism because people who develop memory impairments that can lead to Alzheimer's disease also show an increase in oxidative damage in their brain tissue. Reducing oxidative damage might therefore reduce the risk of dementia. It is important to be screened since memory problems that do not lead to a dementia occur frequently as we age; screening is the first step in helping to identify the true cause of a memory problem. You may wonder why we are continuing PREADVISE screenings, since the supplements in SELECT have been discontinued. Completing memory screenings over the next few years will tell us if taking vitamin E and selenium has any impact on who might develop memory difficulties once these antioxidants were stopped. Of course, this means that participants who did not take either supplement (i.e., the placebo group) remain a very important group in findings about memory changes. In fact, they represent the 'yardstick' for measuring potential benefits or lack of benefits, on memory.

At this time, we have tested our telephone screening program with 62 participants who agreed to centralized follow-up. The response has been very positive. Of course, you still have the right to discontinue your participation in PREADVISE at any time. If you need additional information about memory changes with aging, Alzheimer's disease, dementias, or other brain conditions, please visit our website: http://www.mc.uky.edu/preadvise/ Here you will find information about PREADVISE as well as important links to sites that can provide you with more information. If you have an interest in becoming involved in other studies about memory, dementia, and aging, we would suggest that you visit the Alzheimer's Disease Education and Referral website at: http://www.nia.nih.gov/alzheimers/ Here you will find useful information about exciting studies such as ADNIGO (Alzheimer's Disease Neuroimaging Initiative) and information on treatment studies for dementia. In addition, you can see whether there is an Alzheimer's Disease Center close to you. These Centers can also serve as an important resource for you.

As always, please feel free to contact us with questions or concerns that you might have about the PREADVISE study. You can call us toll free at 866-846-1412 or drop us an email: preadvise@lsv.uky.edu and we'll get back to you. We appreciate your participation and support of this research study.

 

Patricia A. Cassano, PhD, RAS Principal Investigator, Cornell University

Over 15 million Americans have chronic obstructive pulmonary disease (COPD), and it is the fourth leading cause of death in the United States. COPD is a silent disease in its early stages, and it is best detected by a lung function test called spirometry. Knowing that you have COPD is the first step to obtain treatment that could make breathing easier.

The Respiratory Ancillary Study (RAS) will help us to understand whether the supplements being studied in SELECT protect men from developing COPD. The RAS will also help us understand whether the SELECT supplements limit the loss in lung function that people experience as they age. RAS stopped recruiting participants in 2007 after enrolling 2,920 participants at 16 SELECT sites in the United States, Canada, and Puerto Rico. All cigarette smokers at these study sites were invited to participate, as well as a random selection of former and never smokers.

SELECT withdrew study supplements in 2008, but RAS continued to collect lung function tests to get the best possible estimates of lung function in each RAS participant. RAS collected more than 9,000 lung function tests by the time data collection ended in October 2010. My team is currently analyzing the data that have been collected and writing papers for publication in scientific journals. This work proceeds in collaboration with the Coordinating Center and senior scientists in SELECT. In our analysis, we compare men in the different treatment groups to see if men in one group develop COPD less often than men in another group. Thus, all men in the different treatment groups have made important contributions to the RAS!

While many men will participate in the SELECT centralized follow-up, the RAS will not collect any further data. The first RAS findings were prepared for a scientific conference in May 2010. These findings are now the basis of the first publication. The results will be communicated to all SELECT participants, including the men in RAS, via the SELECT website http://www.crab.org/select. We look forward to sharing the study results with the men who made the study possible.

We would like to take this opportunity to extend our sincere and heartfelt thanks to the men who participated in the RAS, and who blasted into the spirometer on multiple occasions in the name of science. Thank you!

For more information about the Respiratory Ancillary Study, contact the SELECT Coordinating Center, or email pac6@cornell.edu. For more information about COPD and lung health, please see this website: http://www.lungusa.org/lung-disease/copd/

 

William Christen, ScD, SEE Principal Investigator, Brigham and Women's Hospital, Harvard Medical School

The SELECT Eye Endpoints (SEE) Study was designed to find out whether the SELECT study supplements can help prevent age-related macular degeneration (AMD) and cataracts, two leading causes of visual impairment in U.S. adults. AMD is a disease that affects the sharp central vision needed for activities like reading and driving, and is the leading cause of severe, irreversible vision loss in older Americans. Cataract is a clouding of the lens of the eye that impairs the vision of more than 50% of adults in the U.S. aged 75 years and older, and is the leading cause of blindness worldwide.

During the course of SELECT, over 100 study sites participated in the SEE study. Participants at these sites who reported a diagnosis of AMD or cataract were asked to sign a consent form giving permission for the release of their eye records. The SEE Center staff at Brigham and Women's Hospital in Boston, which is associated with Harvard Medical School, collected these medical records to obtain details about the reported diagnoses. During the course of SELECT, they were able to collect enough information to answer the study questions pertaining to cataract, but not for AMD.

Therefore, the SEE study is continuing in order to collect additional information about AMD. Regardless of whether your study site participated in SEE, if you have consented to SELECT centralized follow-up, you are potentially eligible to participate in SEE. If you have been diagnosed with AMD, you will be asked to sign a consent that would allow us to collect your medical records. Then the SELECT Coordinating Center will send you a medical release to sign. This medical release will be sent by the Coordinating Center to the SEE Center in Boston. The SEE Center will obtain the medical record information concerning your diagnosis. This additional information collected during centralized follow-up will enable study investigators to answer important questions about this leading cause of irreversible vision loss in U.S. adults. You will have the opportunity to tell us if you were diagnosed with AMD when you get your Annual Booklet during the month of your birth.