1.
What is the purpose of this study? This scientific health study has several goals. Among the most important is to identify reasons why African Americans have higher rates of many forms of cancer than whites. At the same time, information about the causes of cancer in all people, regardless of race, will be gained from this study. Risk factors for heart disease and other common illnesses will also be studied. 2. Who is conducting the study? The study is being conducted by Vanderbilt University in collaboration with Meharry Medical College and the International Epidemiology Institute (IEI). The research team includes scientists in epidemiology and other biomedical disciplines who are members of Vanderbilt, Meharry, and IEI faculty. Also collaborating are staff from community health centers located throughout the Southeast. 3. What is a "cohort study"? A cohort study is a research study whereby a group of persons, the "cohort," is enrolled and then followed over time for the subsequent occurrence of cancer or other diseases. Information on the characteristics of the participants is obtained at enrollment, usually by questionnaire. When follow-up is complete, rates of disease are calculated according to the various characteristics of the participants. Cohort studies have provided much of the information known today about the causes of disease, such as the link between smoking and lung cancer. 4. Where is the study taking place? The study is currently being conducted in the twelve southern states of Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Virginia and West Virginia. 5. How many persons are expected to be enrolled in the study? The expected enrollment is 90,000 adults. About two-thirds of the participants will be African-American. Both men and women will be recruited. 6. Is this the first large cohort study in the South and the first to enroll large numbers of African Americans? This study is the first of its kind in the southern US, and is expected to be one of the largest health studies of African Americans ever conducted. Most health studies typically have had only small numbers or small percentages of African American participants. 7. How are participants recruited for the study? Participants will be recruited from two sources: from community health centers across the twelve southern states, and from a random sampling of the general populations of the states (who will be contacted via the mail). 8. What are the entry criteria for participation in the SCCS? At the time of enrollment, participants must be between the ages of 40 and 79, be English speaking, be willing to provide contact information for follow-up purposes, and not have been under treatment for cancer within the past year. 9. What does participation involve? Participation involves a 50 minute survey, face-to-face in the community health center, or in paper form for the general population sample. The survey covers several aspects of health & lifestyle, including diet, tobacco use, exercise, and personal and family medical histories. Participants are also asked to donate a blood, buccal (mouth), and/or urine sample (the type of sample depending on whether they were recruited in a health center or by mail). An important part of participation is the willingness to be contacted by the study staff periodically in the future, answering shorter follow-up questionnaires. 10. Why are blood specimens being collected? A small amount (less than one and a half tablespoons) of blood is collected and then processed and placed in long-term frozen storage for future assay of markers that may influence the risk of cancer or other diseases. With the rapid technological advances in the study of genes, proteins and other biomarkers, it is expected that tests may become available that can help delineate how our individual bodies may respond to carcinogens or environmental insults in varying ways. By having the biologic specimens stored, the study will be able to test research hypotheses about the causes of disease using these assays. Eventually, such knowledge of the interplay between external and internal factors may help us to develop measures aimed at the prevention of cancer and other chronic diseases within individuals. 11. What are buccal cells and why are they being collected? Buccal cells are cells from the mouth that are obtained by simply swishing mouthwash around in the mouth and spitting it into a plastic container. From the cells collected in this mouth rinse, genomic DNA can be extracted and placed in long-term storage. As with the blood specimens, the buccal specimens can be assayed to see if markers of individual susceptibility to cancer and other diseases can be developed. 12. Is participation voluntary, with informed consent? Yes. Participation is fully voluntary. Each participant signs a consent form that explains the study, what is expected if they enroll, and what their risks, benefits and rights are. The consent form, as well as general study procedures, have been reviewed and approved by Institutional Review Boards at Vanderbilt University and Meharry Medical College. 13. How long will the SCCS keep in contact with study participants? It is anticipated that the follow-up will continue for many years. The initial funding is from a 5-year grant provided by the National Cancer Institute of the National Institutes of Health, but it is expected that the study will continue for 10 or more years. 14. What do SCCS study participants receive in return for their time and trouble? Several benefits may accrue to the study participants, some of which are intangible:
15. Who is paying for this study? Funds for the SCCS are being provided by a grant from the National Cancer Institute (National Institutes of Health). 16. Who will benefit from this study? Within a few years, we expect to begin to report useful information about cancer and heart disease that could improve the health of residents of the southern US, specifically, and the entire human population ultimately. By determining the reasons why African Americans have higher rates of most forms of cancer, we may be able to develop preventive strategies to lower the rates of cancer not only among African Americans but among all racial groups. The biologic specimen repository will enable laboratory studies that could make far-reaching contributions to cancer, heart and other disease studies for decades to come. The children and grandchildren of this generation may be able to avoid certain risk factors for these diseases thanks to what we learn from the life experiences of the 40 to 79 year-olds of today. |
