The Ramazzini Institute
for Occupational and Environmental Health Research   

Who Are We?

     Under the direction of William N. Rom, MD, MPH, President of The Ramazzini Institute and Director of the Pulmonary Division of New York University School of Medicine, an occupationally-oriented Lung Cancer Biomarker Center has been established as part of the National Cancer Institute's Early Detection Research Network. Co-Principal Investigator is Arthur Frank, MD, PhD, also an officer of the Institute, of the University of Texas Health Center at Tyler and Hahnemann School of Public Health in Philadelphia. The Institute assists the Center in recruitment of patients, as an ethics monitor, and through its primary mission as a consortium facilitator. 
     The mission of the Center is to develop new and more effective methods of identifying pre-cancerous cell changes and lesions and to detect lung cancer at a very early stage. The Center is able to closely monitor those who show any signs of having pre-cancerous cells and refer workers to treatment programs earlier to increase their chance of survival. 
     Now in its third year of operation, the Center is focused on those at highest risk of lung cancer, namely those with a history of smoking (=20 pack-years) and workplace exposures to known causes of cancer, such as asbestos, solvents, and ionizing radiation. 
     Patients currently are drawn from two populations: 

• utility workers, asbestos insulators, boilermakers, sheet-metal workers, carpenters, pipefitters and other former and active union members who have had significant past asbestos exposures in the New York Metropolitan area, and 
• active and former workers at the Department of Energy's Pantex Nuclear Weapons Facility in Amarillo, Texas, recruited through the Amarillo Health Consortium organized by the Amarillo Metal Trades Council of the Metal Trades Department, AFL-CIO and The Ramazzini Institute. 

     The total number of workers in the program is limited to about 1500 individuals, who will have access to the earliest cancer detection tests and may have access to new ways to interrupt the chain of events that lead to cancer. 

Interim Results

     During the past year at the NYU Center, more than 600 individuals have been evaluated with spiral chest CT scan, spirometry [a breathing test], sputum, blood and questionnaire for respiratory symptoms and occupational exposures. Nineteen patients have returned for recommended annual follow-up screening. In Texas, more than 300 current and retired Pantex Nuclear Weapons plant workers have been screened with chest radiographs, spirometry, sputum, and blood. 
     Sputum cytology has revealed cases of pre-cancerous changes in cells. Spiral CT revealed cases of possible early cancer. Chest radiographs detected cases of lung cancer, including mesothelioma. These cases have all been referred for appropriate clinical surveillance and treatment.
     The New York University Center is specially equipped to use advanced methods of bronchoscopy for diagnosis, including fluorescent bronchoscopy. Both populations are providing blood and sputum, which will be analyzed to see if changes in cell structures and chemical changes and mutations in the DNA can be detected of the p53, K-ras, and Rb genes, and associated enzymes, in the web of factors that promote or suppress cancer. 
     From these studies, new tests are being devised to detect pre-cancerous conditions or to be used in treating cancer in the earliest and most treatable stages. Possible new treatments are being devised based on identifying cancer-suppressing genes whose function may have been silenced by cancer promoting chemical changes or by deletion. These tests will use DNA from blood, sputum or bronchial brushes. Center scientists are also looking at genes in actual lung cancer resections and evaluating gene expression in microdissected pre-cancerous lesions. Hopefully these tests will lead to novel approaches to identify lung cancer at its earliest stages, and provide a rationale for future chemoprevention studies in individuals at high risk. 
      A special advantage of the Center is its active participation in the National Cancer Institute's Early Detection Research Network. Advances in detection and treatment developed at other research centers are shared and, where appropriate, applied in cases found by the Lung Cancer Biomarker Center among populations of workers. 

Special Ethical Protections

     In addition to the multiple levels of protections for confidentiality and privacy afforded by National Institutes of Health regulations, including Institutional Review Boards at the University of Texas, Hahnemann School of Public Health, and New York University, recruitment, education, and follow-up procedures are monitored by The Ramazzini Institute, which serves as a volunteer ombudsman and reviews research and follow up procedures to insure that they are designed to protect participants in the program by insuring involvement, information and true choice. 

President Emeritus and Board Chair: Arthur C. Upton, MD, Clinical Professor of Occupational and Environmental Medicine, University of Medicine and Dentistry of New Jersey*

President: William N. Rom, MD, MPH, Professor and Director, Division of Pulmonary Medicine, New York University School of Medicine*

Vice President: Sheldon W. Samuels, Director Emeritus of Health, Safety and Environment, Industrial Union Department, AFL-CIO*

Treasurer : Arthur Frank, MD,. PhD, Professor of Environmental and Occupational Health at Hahnemann School of Public Health [July 1, 2002] .

Director: Paul Brandt-Rauf, MD, PhD. Chair, Department of Chair of the Department of Environmental Health Sciences at Columbia University’s School of Public Health [July 1, 2002] .

Director: Patricia A. Buffler, PhD, MPH, Professor of Epidemiology and Dean Emerita of the School of Public Health, University of California at Berkeley.

Director: Michael Flynn, President, CREST: International Association of Machinists and Aerospace Workers

Director: Antonio Giordano, MD, PhD, President, Sbarro Institute and Professor of Biology and Medicine,
College of Science and Technology, Temple University*

Director: Ivan Gut, MD, PhD, DSc, Center of Hygiene and Occupational Diseases, Czech Institute of Public Health

Director: Philip J. Landrigan, MD, DIH, Professor and Chair, Community Medicine, Mt. Sinai School of Medicine*

Director: Tor Norseth, MD, PhD, Senior Toxicologist, Norwegian Occupational Health Institute

Director: Knut Ringen, DrPH, MHA, MPH, Occupational Health Consultant, Seattle, Washington

Director: Hans-Joachim Woitowitz, MD, PhD, Professor and Director, Institute for Occupational And Social Medicine, Justus Liebig University of Giessen, Germany

Director: Charles Xintaras, DSc, Environmental Health Scientist, Athens, Greece