In 1996, Jerome L. Belinson, MD, then Chairman of the Department of Obstetrics and Gynecology at the Cleveland Clinic Foundation in Cleveland, Ohio, and a Gynecologic Oncologist, read about an area in China with a high prevalence of cervical cancer and a mortality from cervical cancer 10-20 times most areas in the developed world. Around the same time he became friends with Mr. Anthony Yen a long time United States citizen with major political and industrial connections in China.
Dr. Belinson was especially interested in exploring cervical cancer prevention and exploring ways to reach the women of the world who had never been screened for cervical cancer. Knowing clearly that studying a disease is far easier in areas with high rates of the disease in question Dr. Belinson began to try to establish a research contact in China. Yan Xu, PhD, a cancer biologist whom Dr. Belinson worked with at the Cleveland Clinic, contacted her father a biochemist at Peking University in Beijing, China. He suggested contacting Zei Wei Dong, PhD. the (at that time) Director of the Cancer Institute Hospital of the Chinese Academy of Medical Sciences (CICAMS). Dr Dong then referred Dr Belinson’s inquiry to Youlin Qiao, MD.,PhD, and the critical link was made. Dr. Qiao was and still remains the Head of the Department of Epidemiology at CICAMS and at that time had ongoing collaborations with the NIH in the areas of Esophageal Cancer, and in Lung Cancer occurring in tin mine workers. He had spent 11 years in the United States, received his PhD from Johns Hopkins University and then returned to China to assume his role at CICAMS. At the time he and Dr. Belinson first began to communicate, Dr. Qiao had done a few limited surveys concerning the prevalence of cervical cancer in some regions of China, but no formal studies.
A memorandum of understanding to collaborate was formally signed in Cleveland, Ohio in 1997 during one of Dr Qiao and Dr Dong’s visits to the NIH. Realizing the opportunity that existed Dr. Belinson contacted a few of his associates in particular Robert G. Pretorius, MD., from Kaiser Permanente in California and posed the question: “If you had access to a large unscreened population with very high rates of cervical cancer what would you like to do?” The result of these discussions was the goal, “To develop a low cost screening algorithm sensitive enough for CIN II, III, and Cancer, and specific enough for CIN II and III, to allow ablation of the cervical transformation zone without histologic confirmation”. This has remained a primary goal of our cervical cancer work to date.
In the beginning we believed we needed to determine the true sensitivity and specificity of multiple screening modalities. An initial clinical trial was then designed by Drs Belinson and Pretorius, and a research group established with the goal of blending humanitarian work with good science. This organization is today Preventive Oncology International Inc.
The American and Chinese team was assembled. The principle members of the original 62 member research team and their positions at that time were:
- Dr. Belinson – Chairman, Department of Obstetrics and Gynecology, Cleveland Clinic Foundation
- Dr. Qiao – Head, Department of Epidemiology, Cancer Institute/Hospital of Beijing, Chinese Academy of Medical Sciences
- Dr. Pretorius – Head, Gynecologic Oncology, Department of OB/GYN, Kaiser Permanente, Fontana California
- Dr. Zhang – Head Department of Gynecologic Oncology, Cancer Institute/Hospital of Beijing, Chinese Academy of Medical Sciences
- Dr. Pan – Head, Department of Cytopathology, Cancer Institute/Hospital of Beijing, Chinese Academy of Medical Sciences
- Dr Biscotti – Head, Cytopathology, Department of Anatomic Pathology, Cleveland Clinic Foundation
- Dr Li – Pathologist, Department of Pathology, Cancer Institute/Hospital of Beijing, Chinese Academy of Medical Sciences
- Dr Elson – Biostatistician – Cancer Center, Cleveland Clinic Foundation
- Mr. Rong – Field Supervisor, Department of Epidemiology, Cancer Institute/Hospital of Beijing, Chinese Academy of Medical Sciences
- Mr. Craig Fisher, Technical Advisor, Optical Biopsy Inc, Knoxville Tenn.
- Mr. Anthony Yen, Yen Enterprises, Cleveland, Ohio.
From the beginning of our studies in China we have been aided by the governmental support and approval we have received with the assistance and advice from Mr. Anthony Yen. In addition early in our work we made the decision to process and evaluate all specimens in China rather than risk extensive transport and potentially unpredictable customs and specimen storage. Therefore to date we have established liquid based cytology laboratories (both ThinPrep, Hologic Inc., and SurePath, TriPath Corp), testing for human papillomavirus, HPV by Hybrid Capture II, ( Qiagen Corp.), Aptima (Gen-Probe Inc.), Cervista (Hologic Inc.), PCR for HPV typing (Roche Linear Array), and a lab for computerized fluorescence microscopy. Some quality control work has been done in the United States. In addition we have stored and banked specimens of slides, tissue, cells, and DNA for future collaborative projects.
Dr. Qiao has formed the Chinese Consortium for the Study and Prevention of Cervical Cancer which has members throughout China. The Health Ministry in China has published guidelines for the prevention of cervical cancer based significantly on our prior work in collaboration with Dr Qiao. In 2006 we established a new research collaboration with Peking University Shenzhen Hospital to work in Southern China. Beginning in 2009 we developed a collaboration with BGI Shenzhen (the largest sequencing facility in the world) and together we have significantly improved self-collection, developed a new HPV next generation sequencing assay and now have developed a community based model to enable large screening efforts to reach the people most in need. We continue our studies in China as well as other countries to explore ways to further our mission of prevention, buoyed by our past success.