Support of epidemiologic research into the causes of cancer has been a major focus at Westat for more than 35 years.
Providing Cancer Clinical Trials Support Through the CTSU
The Cancer Trials Support Unit (CTSU) has collaboratively developed support services integrated with a complex information technology infrastructure that supports clinical trial operations.
Westat has played a coordinating role in the launch of NCI’s National Clinical Trials Network and Experimental Therapeutics Clinical Trials Network. These new networks constitute a reengineering of the entire cancer clinical trials system to take advantage of efficiencies gained by standardizing processes and harmonizing systems.
Westat's services include
o Collaboratively developing and implementing key information systems
o Providing patient enrollment and randomization services with 24/7 availability
o Maintaining a national roster of investigators and institutions
o Collecting and distributing institutional review board approval records
o Operating a Help Desk service
o Operating a comprehensive website and applications portal
o Developing and distributing promotional and educational material
o Providing clinical data management
The CTSU has efficiently and effectively provided these services and adapted them to the changing demands of the cancer clinical trials environment since the inception of the program in 1999. The CTSU has supported more than 290 clinical trials, enrolling more than 70,000 patients from more than 1,200 institutions.
Keeping Tabs on Cancer with the Maryland Cancer Registry
The Maryland Cancer Registry (MCR) collects cancer reports from hospitals, radiation therapy centers, ambulatory care facilities, and freestanding diagnostic laboratories in hopes of understanding the ways cancer impacts Marylanders and finding better ways to treat it.
Westat provides assistance to the MCR. We receive and process all cancer reports, following steps to ensure security, confidentiality, and data integrity. We also develop monitoring reports to provide feedback and identify and address any issues.
Under Westat’s leadership, the MCR’s national cancer registry submission results have shown a track record of improving timeliness, completeness, and accuracy of reporting.
Does Cancer Screening Save Lives?
Westat has served as the coordinating center for the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial since its inception. The trial originally recruited more than 150,000 people aged 50 to 74 at 10 clinical centers, randomized them to a screening or control arm and continues to follow them longitudinally collecting data on cancer incidence and mortality. After 20 years of data collection at each clinical center, the study has moved to centralized followup, carried out by Westat.
PLCO has already helped researchers answer important questions about the early detection value of PSA testing for prostate cancer, chest X-ray for lung cancer, flexible sigmoidoscopy for colon cancer, and CA125 and ultrasound for ovarian cancer.
Westat staff contributed to a report on the efficacy of screening with flexible sigmoidoscopy for colon cancer, which appeared in the New England Journal of Medicine. Screening was associated with a significant decrease in colon cancer incidence and mortality.
Westat is continuing active data collection with PLCO participants, physicians, and medical records and pathology departments through the Central Data Collection Center (CDCC). The CDCC also conducts passive data collection activities such as submissions to state tumor registries for data linkage and National Death Index searches.
Examining Patient Navigation to Promote Colonoscopy Screening
The Centers for Disease Control and Prevention’s (CDC’s) National Center for Chronic Disease Prevention and Health Promotion tapped Westat expertise to evaluate the feasibility of developing a public health-based patient navigation model to increase adherence to colonoscopy screening.
Westat conducted a literature review and environmental scan to assess the patient navigation evidence base and to inform the design of a patient navigation intervention and associated research design. We also conducted interviews with many patient navigation programs across the country.
We gathered and evaluated existing questionnaire items, developed new questionnaires, and conducted cognitive testing interviews to refine the questionnaires.
Westat researched various behavioral theories to develop a scientifically tested, theory-based patient navigation model that is replicable by public health partners.
In collaboration with CDC investigators, Westat defined the procedures for recruitment, intervention, and followup.
We also explored potential study sites to ensure a racially and ethnically diverse clinic population of appropriate age, as well as a large enough patient volume to meet the recruitment goals set forth in the research design plan.
Researching Cancer in Bone Marrow Failure Syndromes
Westat is providing research support services to the National Cancer Institute's Clinical Genetics Branch to study families with Inherited Bone Marrow Failure Syndromes, and analyze how various factors can affect the course of the diseases, particularly the connection between these syndromes and cancer.
Westat is recruiting participants, determining eligibility, and collecting individual and family medical history and risk factor information. Clinical assessments of study participants at the National Institutes of Health Clinical Center (CC) is coordinated by Westat, as well as the acquisition of medical records and pathology from outside institutions. Biological specimens, such as blood, tissue, and saliva are being collected from participants at the CC or at their local physician’s office, and distributed to nearly 30 collaborating laboratories. Study data is managed by Westat and analytical data sets are built using data processed by Westat, as well as that from outside collaborators.
This study has led to the discovery of a number of genetic mutations associated with these syndromes. Research data has also contributed to the use of additional diagnostic tools for these syndromes. The research findings have resulted in numerous publications. To learn more about the study or to find links to the publications, visit http://marrowfailure.cancer.gov
Understanding the Causes of Burkitt Lymphoma in African Children
Burkitt lymphoma, a non-Hodgkin's form of lymphoma, is a cancer that begins in the body’s immune cells. Outside of Africa, it is rare, but within Africa, it is common in young children who also have malaria or the Epstein-Barr virus. To help learn why, Westat has been providing research support to the Epidemiology of Burkitt Lymphoma in East African Children and Minors (EMBLEM) study.
EMBLEM is sponsored by the National Cancer Institute and is conducted in collaboration with researchers in Uganda, Tanzania, and Kenya. Westat’s wide range of support activities include subcontracting with local sites, providing study management guidance to improve communication and overall study performance, developing tools for tracking field activities, and providing feedback to sites. These tools have been enthusiastically received by investigators and field staff as they coordinate efforts in six sites in the three East African countries. We have also developed a scientific protocol for evaluating field methods of malaria diagnosis and negotiated with Partec, a German biotechnology vendor, to supply equipment, materials, and training for the study.