Extended Follow-Up Frequently Asked Questions

1. What is the PLCO Central Data Coordinating Center?

The PLCO Central Data Coordinating Center (CDCC) is an extension of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. The extension will be coordinated by one site under the direction of the National Cancer Institute (NCI) rather than ten PLCO Screening Centers to reduce costs. Westat which has served as the PLCO Coordinating Center will also serve as the CDCC.

2. Why is the National Cancer Institute (NCI) extending the follow-up of PLCO participants?

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial has proven to be a valuable resource for research in cancer prevention and molecular epidemiology. NCI is extending the follow-up of PLCO participants for at least five years in order to strengthen the scientific value of this study in determining if the screening and early detection reduce deaths from prostate cancer, lung cancer, ovarian cancer, and cancers of the colon and rectum. The PLCO extended follow-up will also look for factors which may cause many types of cancer and other diseases.

3. Why am I being asked to consent to be transferred to the CDCC?

NCI is extending the follow-up of PLCO participants for at least an additional five years in order to strengthen the scientific value of this study in determining if screening for prostate cancer, lung cancer, ovarian cancer, and cancers of the colon and rectum reduces deaths from those cancers. In the future, CDCC staff will be contacting you to obtain information about your health. You originally consented to only allow the PLCO Screening Centers to hold your contact information. The PLCO Screening Centers need your permission before they can transfer this information to the CDCC.

4. What are the differences between the transfer options (active, passive, or withdraw)?

ACTIVE: If you agree to active follow-up by the CDCC, your identifying information will be transferred to (the CDCC, Westat). The CDCC will contact you with the annual questionnaires, as well as follow-up on any cancer diagnoses (as your PLCO site had done). Your information will be protected by the CDCC, just as they have in the past by the sites. Your name and other information will not be released without your permission and there are several safeguards in place to protect the electronic data (password controls, etc.).

PASSIVE: If you choose passive follow-up by the site, you will not be contacted. Instead, information you have supplied in the past will be used to search databases and tumor registries to determine if there has been a cancer diagnosis.

WITHDRAW: If you choose to withdraw from the study, you will not be contacted in the future.

5. What will I have to do, if I transfer to the CDCC?

As a participant in the PLCO Cancer Screening Trial, nothing you do will change. The only difference is that the NCI's CDCC will do what the Screening Centers had been doing. This includes sending the annual questionnaires and other mailings, such as the newsletters and cards, to you. If you had surgery for diagnosis or treatment of cancer or a related condition, the CDCC may request a copy of your medical records to document your diagnosis and treatment. The CDCC may also ask your doctors and the hospitals where you were treated to provide a small sample of the tissue that was removed for your diagnosis or treatment. The CDCC will also search state vital statistics databases to collect information on your health.

6. What if I do not wish to be transferred to the CDCC?

Your participation in the PLCO Cancer Screening Trial is completely voluntary and you may refuse to participate and/or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.

Alternatively, if you do not want the NCI CDCC to get your information, but are still willing to stay in the PLCO Extended Study, you can choose to be a passive follow-up participant. Your information will stay at the screening center. We will not call or mail you annual questionnaires, but screening center study staff will search state health registries and vital statistics databases to continue to collect information on your health

7. If I choose active follow-up but would like to withhold the transfer of my social security number, is that possible?

Yes this is possible. We have procedures in place that we can withhold the transfer of your social security number if you request it.

8. What is the best option to choose for the study?

The choice of active follow-up contributes the most information to PLCO allowing the investigators the most complete 'picture' of what has happened to the study participants over the years. But it is entirely your decision and you need to choose the option that works best for you.

9. Why is the Federal government is taking over the study? Is the site PLCO staff retiring from the study?

In order to lower costs, the PLCO Screening Center staff is being reduced and study coordination is being transitioned to the CDCC. A small number of people will remain at the site to conduct the passive follow up of those participants who chose that option. The Principle Investigator at each site will remain active with the study to continue to evaluate the data and collaborate on publishing the study results.

10. Will there be security to safeguard against identity theft during the transfer?

There will be security policies implemented for the transfer process. This involves the use of encryption and pass codes to access the data during transfer. Data will be stored in locked cabinets and locked rooms with limited access during this time. Softwares and procedures in place exceed governmental standards (such as DoD 5220.22-M, NAVSO P-5239-26, etc.). Once transferred, access to systems will be further controlled through two-factor authentication with the second factor a SecureID RSA fob and role-based authorization.

All personnel accessing data in any capacity will complete the requisite security trainings including the NIH Computer Security Awareness Training and the Westat Human Subjects Protection Training. All staff will also undergo a background investigation commensurate with Moderate FISMA requirements and will sign a Non-Disclosure Form for the contract.

On completion of the contract, all electronic and hard copy data will be archived/destroyed as directed by the NCI.

11. What are the risks?

This research project involves no more than minimal risk and does not affect your health care benefits or any other benefits you may receive. There may be a minor risk of unintended disclosure of personal health information. The CDCC is taking appropriate measures to protect the confidentiality, integrity, and availability of information and information systems in accordance with federal government requirements.

12. What are the benefits?

The study will not provide any direct benefit to you other than the satisfaction of participating in this research for the possible benefit of future generations. However, your participation will help answer questions related to the health and longevity of persons in your age group and will help establish a scientific understanding of the factors which influence the development, and progression of cancer and other diseases.

13. How will my personal information be used?

The personal information you provide (such as your name, address and date of birth) will be necessary for the CDCC to contact you for the extended follow-up. In addition, your personal information may be used to search state health registries and vital statistics databases to continue to collect information on your health. All your personal information will be kept confidential, and will not be disclosed or used by anyone other than the CDCC staff and researchers without your consent. The results of research from the PLCO trial will be presented at meetings or in published articles, but only in aggregate. Your name or any other personal information will not be used.

14. Who is maintaining the CDCC?

Westat has been contracted by the NCI to be the CDCC. Westat has served as the Coordinating Center for the PLCO Cancer Screening Trial since the beginning of the Trial in 1993 and as such, they have extensive knowledge of PLCO and are familiar with the data security and confidentiality requirements for the PLCO study.

15. Where is the CDCC located?

The Centralized Data Coordinating Center (CDCC), is located at Westat which is headquartered in Maryland near the National Cancer Institute in the Washington DC Metropolitan area.

16. How do I contact the CDCC?

If you want more information you can reach Chris Miller the CDCC Study Manager, by calling 888-886-0750 or by faxing 301-212-3744. You can also send correspondence to the CDCC at the following mailing address:

Chris Miller
1600 Research Blvd. GA-L60
Rockville, MD 20850