Using a scientifically selected study sample, UNC researchers will contact the physician of record prior to contacting the patient about the study.
Robert Millikan, D.V.M., Ph.D., Barbara Sorensen Hulka, Distinguished Professor of Epidemiology in the UNC Gillings School of Global Public Health, is the studyâ€™s principal investigator. Mary Beth Bell, project manager of the Carolina Breast Cancer Study, is coordinating the project team, which includes nurse interviewers, recruitment specialists, outreach coordinators and others. The study is supported by the University Cancer Research Fund.
â€œBlack women under the age of 50 have a high mortality rate from breast cancer, almost twice that of younger White women,â€ Millikan said. â€œWe will address this pressing health disparity by enlarging upon the Carolina Breast Cancer Study, which enrolled over 2,300 women with breast cancer and 2,000 control subjects between 1993 and 2001.â€
One of the Lucas studyâ€™s primary aims is to investigate subtypes of breast cancer, continuing discoveries made by the Carolina Breast Cancer Study. Data from the existing study were key to a 2006 finding by a UNC Lineberger team that included Millikan, molecular biologist Charles Perou, Ph.D., associate professor in the departments of genetics and of pathology and laboratory medicine in the School of Medicine, and breast cancer specialist Lisa Carey, M.D., associate professor of medicine in the School of Medicine and medical director of the UNC Breast Center. They found that premenopausal Black breast cancer patients have the highest prevalence of a subtype of breast cancer called â€œbasal likeâ€ cancer.
â€œBetween now and 2012 we will enroll an additional 1,000 Black women with newly diagnosed cases of invasive breast cancer â€“ half under the age of 50 and half aged 50 and older â€“ and a similar number and distribution of White women with breast cancer,â€ Millikan said. â€œThe Lucas Study will more than double the number of Black breast cancer patients in the original study. We will also follow the 2,000 women for two years following diagnosis to examine disparities in treatment and access to care.â€
Millikan said the help of doctors and hospitals would be key to the studyâ€™s success.
â€œSince this study is not one for which women can volunteer, the help of physicians is vital to us as we reach out to recruit participants in these counties,â€ he said.
For the study results to be unbiased, women must be selected through a scientific randomization process, and an equal number of Black women and White women will be recruited over a four-year period.
No treatment of any kind will be given as part of the study. Participants will be interviewed in their homes by trained nurses regarding breast cancer risk factors, and a DNA blood sample will be taken to help determine factors that women with breast cancer have in common. Researchers will also request patientsâ€™ permission to access their medical records relating to breast cancer diagnosis and treatment.
An advocacy board consisting of breast cancer survivors and others interested in various aspects of breast cancer research has been established to guide the study design and the entire study process.
â€œWe are committed to the success of this study as we have evidenced the devastating impact of breast cancer in young African American women,â€ said Valarie Worthy, president of the Sisters Network Triangle NC.