|Name of Biobank
||Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Biorepository
|Primary objective (one sentence)
||To facilitate etiologic and early marker studies in the PLCO cohort.
|Key components (please briefly address the following):
- Enrollment: 1993-2001
- Regular annual follow-up: 1993-2011
- Planned extended follow-up: 2011-2015
|Sample size (current and anticipated) and characteristics (age, gender)
154,910 total trial participants
- 76,693 Males; 78,217 females
- 77,449 in the intervention arm; 77,461 in the control arm
- 55-74 at enrollment
- ~65,916 with serum samples
- ~112,500 with DNA samples
- ~9,618 cancer cases (all sites) with serum sample available
- ~12,953 cancer cases (all sites) with DNA sample available
|Recruitment area, method of recruitment/follow-up, sample representativeness
Recruitment was carried out at the following 10 centers:
- University of Alabama at Birmingham
- Henry Ford Health System
- University of Colorado
- Pacific Health Research Institute
- Marshfield Clinic Research Foundation
- University of Minnesota
- University of Pittsburgh
- University of Utah
- Washington University
- Georgetown University Medical Center
Follow-up was carried out by the same centers through annual administration of a questionnaire.
Blood samples were collected from all intervention arm participants who provided the consent. Buccal cell samples were collected from all control arm participants who provided the consent.
|Types of data/specimens collected (questionnaire, physical exam)
- Family history of cancer
- Personal medical history
- Life style
- Screening test results
- Any cancer diagnosis
Pathology tissue specimens (FFPE) for selected cancer sites (Colorectal, ovary, prostate, lung and breast)
- Serum (intervention arm only)
- Plasma/Buffy coat/Red blood cells (intervention arm only)
- Buccal cells (from control arm participants only)
|Data collection, storage, processing systems
||The biospecimens data are stored and tracked with a commercial system called “BSI II, Biological Specimens Inventory System”, under a contract with IMS. BSI allows efficient management and tracking of specimen requests and workflow.
Other data management systems were developed to support data entry, editing, and sharing of various trial-related data (questionnaires, screening examination forms, medical record abstract forms, annual study updates, blood collection forms, etc.). These systems are a combination of commercial, off-the-shelf software and applications developed specifically for the trial under contract with Westat. Data are generally collected on forms designed for an optical-mark reader. Forms are scanned and primary edits on key field are automatically produced. Data are edited manually as needed through the “data entry and editing system”. These data systems are synchronized with the main trial study management system that records trial activities.
|Method of consent, reporting of results
The main study consent was obtained from all PLCO participants prior to randomization. A second consent, called an Etiologic Studies Consent (ESC), was obtained from those participants who agreed to provide blood or buccal cells for future research. The ESC was implemented in March 1998.
Prototype consent forms were used as a guide by each screening center (SC) in the development of its own informed consent form(s). The individual SC consent form(s), once developed, was reviewed and approved by the NCI first and then the local IRB.
The main study consent covers the following areas of protection:
- Each participant must be fully informed of all study procedures and requirements in order to be considered a “knowing” participant;
- The study design must minimize risks to the participants and maximize the benefits;
- The study participants must be selected in a non-discriminatory way so that no class of individuals will benefit more than any other based on the selection procedures; and
- Participation is voluntary and all information provided by participants will be kept confidential.
The Etiologic Studies Consent obtains permission to use biologic specimens, already collected, for research involving genetic studies. It also obtains permission for future collection of blood, buccal cells (saliva) and pathologic tissue, and for the use of those samples for research involving genetic studies.
The method of administration of the consent forms varies by Screening Center. In some instances, the form was mailed to the subject, in others it was administered in-person. Regardless, administration of the form occurred after the subject had been provided with background information about the study and its requirements. This information includes an introductory letter, the PLCO Study Brochure and, in some instances, a conversation with the SC Coordinator in a manner conducive to two-way conversation. The participant was offered sufficient time to carefully read the document and given sufficient opportunity to have all questions answered before s/he was asked to make a decision about the consent.
The status of the consent is recorded in the data management system as signed, refusal or missing. Various reports were used to monitor the results of obtaining the consent. In the BSI, each specimen is marked with the consent status. Only specimens with appropriate consent are used for research.
|Health outcomes of interest
||The primary endpoint of the PLCO trial is cancer-specific mortality for prostate, lung, colorectal and ovarian cancer, although all-cancer incidence was recorded, allowing etiologic and early marker studies of all cancers.
||National Cancer Institute, NIH