Overview

In brief…

Our History

Preventive Oncology International, Inc. (1997- present)

Preventive Oncology International, Inc. (POI) was established in 1997, and became the international research arm of the Division of Gynecologic Oncology in the Department of Gynecology and Obstetrics at The Cleveland Clinic in Cleveland, Ohio. On the 29th of July 2008, with the retirement of it’s founder Jerome L Belinson MD from clinical practice at the Cleveland Clinic, POI became its own 501(c)3. In 2010 a formal legal affiliation was established with the Women’s Health Institute at the Cleveland Clinic.

To date POI has conducted research in China, Malaysia, Mexico, Peru, USA., Dominican Republic and collaborated with research groups working in India, Haiti, Kenya, Brazil, The Netherlands, Belgium, and the USA.

Twenty U.S. based students, residents, and fellows have done research with POI. Their participation and the studies’ data were used to complete educational requirements and contributed to several students earning their master’s degrees in public health (MPH) and a Doctorate in Epidemiology (PhD). An equal number of graduate students from China have also worked with POI in order to complete advanced degrees.

POI has had consistent guiding principles:

To blend clinical care with our research, particularly in medically underserved communities.

To always have a POI staff or a devoted collaborator on site, but primarily work with an “in-country” research team plus local (community) caregivers.

– Raise funds for POI per project.

Conduct only investigator initiated (designed) clinical trials.

Work with researchers as a functional team, focused on the design and quality of the research, rather than the order of manuscript authorship.

POI is a simple organization that makes things happen efficiently; always conducting our research carefully with the highest respect and gratitude for the women who have consented to receive our care and thus participated as “subjects” in our clinical trials. Over the past 27 years we have worked side-by-side with hundreds of physicians, nurses, clinical assistants, and graduate students; we are indebted to the many people (and their families) who have worked in our clinical investigations, and we genuinely hope they feel their participation provided value for their lives and that they felt the respect and gratitude we had for them for joining us in our work.

An overwhelming feeling of decency and benevolence has been experienced by our workforce each time we entered a rural village and realized: the only reason the women were going to receive medical care was “because we were there.”

Our Thanks

It is essential to recognize that due to the “in-country” model we followed, there are a few individuals who allowed us to enter their lives, and without whose guidance and expertise the past 27 years would never have occurred.

China (27 years):

            We will be forever grateful that my letter to Zhi Wei Dong PhD, the Director (in 1997) of the Cancer Institute/Hospital in Beijing of the Chinese Academy of Medical Sciences was handed to Professor You-Lin Qiao MD PhD, the Chief of Epidemiology at CICAMS. This most critical step allowed EVERYTHING that followed to occur.

Dr Qiao and the Chair of Gynecologic Oncology, Dr Wen Hua Zhang were the principal organizers and clinical facilitators of all of our trials for the first decade. As stated earlier, many other critical personnel: clinicians, pathologists, cytologists, laboratory technicians, nurses, clinical assistants, statisticians, administrative staff from Beijing, and local clinicians and staff from the multitude of villages in the many Provinces where we conducted research helped form our team.

Each “in-country” organizational charts can become very complex with the multitude of individuals whose work was essential to each study’s success. For our initial trial in China “SPOCCS I” (Shanxi Province Cervical Cancer Screening Study) our research team consisted of 62 persons, both US and Chinese.

In 2008-9 we moved the center of our work in China to Shenzhen, Guangdong Province, in Southern China. The Peking University, Shenzhen Hospital (PUSH), was the only hospital in the Peking University Hospital System located outside of Beijing (Peking). The leader of the Department of Obstetrics and Gynecology for more than 20 years became the most important person for our work in China for the next 15 years. Professor Ruifang Wu MD as a strong leader, and a clinician genuinely interested in research and education became our leader and dear friend. Led by Professor Wu, we traveled as a team to provide care for tens of thousands of women in our clinical trials.  There 5 other individuals in Shenzhen, whose work, time, and commitment need special mention: Hui Du MD (clinician); Xinfeng Qu MD (Steve, administrator and great friend); Guixiang Wang MD (clinician); Chun Wang MD (Pathologist); and Yuen Chen MD who as leader of PUSH facilitated local politics and the support from the Shenzhen Female Doctors Association for our work.  It is also critical to mention the guidance both clinical and political our work received from the esteemed Professor and Chair of the Department of Obstetrics and Gynecology at Peking University People’s Hospital in Beijing Professor  Lihui Wei MD.

Our work introduced HPV testing and liquid based cytology into China for cervical cancer screening. It is also noteworthy that Professor Qiao translated our foundational work into expanded clinical care guidelines by forming the Chinese Cervical Cancer Consortium which eventually covered most provinces in China. In regard to continuing education, Professor Wei did the same, in leading the creation of the Chinese Society of Colposcopy and Cervical Pathology (related to the ASCCP in the USA).

Mexico (10 years):

            The singular individual most responsible for contacting the communities (including indigenous populations), negotiating the politics, setting up the labs, and the movement of supplies was Christine Enerson, MD.  Dr Enerson also graciously participated in our clinical work.

Peru (3 years):

            Glorious Peru was the second site for our progressive development of our community-based screening models: first in Manchay, a squatters village on the outskirts of Lima; and then in seven villages in the lower Amazonian region in Iquitos. Carlos Villejos Solgeron, MD., and his daughter Majo (Maria Jose Villejos) were our key facilitators. We are indebted to the de Osma family for their support and hospitality in Peru. We are especially grateful to our dear friend from Mexico, Jorge Salmeron, MD. MPH. PhD, who joined our research team and most critically guided us through the nuances of South American politics and Spanish culture keeping us on track for our work.

Dominican Republic (1 year)

            The site of our initial work with optical coherence tomography. All was organized and made possible by Luis Rojas Grullón MD.

Our Staff

POI Staff and key team members

From the Cleveland Clinic, University Hospitals in Cleveland, Ohio we have been joined by students, residents, many gynecologic oncology fellows, and staff (especially from the Department of Pathology), all contributing to the success of our work.

Over the past 27 years, the POI staff, underwent just a few changes, but has always been limited to those vital to our work.

Current:

Jerome L. Belinson MD. Founder and President of Board

Robert G. Pretorius MD. Founder and Vice President of Board

Bin Yang MD PhD. Pathologist and Secretary/Treasurer of the Board

Shane Millette – Chief Financial Officer

Nancy Tresser Lipko MD – administrative coordinator (US based)

XinFeng Qu MD – administrative coordinator (China based)

Past Years:

Mary Mohr MHA, MSN, RN – Executive Director for 10 years

Monique Washington RN – first administrative/clinical coordinator

Donna Fife RN – second administrative/clinical coordinator (China based)

Guixiang Wang MD – field coordinator (China based)

Suzanne E. Belinson MPH. PhD. Epidemiology, Biostatistics, and board member

Sarah Hayes – Bookkeeper

Dennis Siciliano – Legal Council

Sources of Funding

a partial list containing most, but not limited to:

            Our initial trip for our first pilot trial in China in 1997 was funded by a generous gift from Jane Horvitz in Cleveland, Ohio. It will always be appreciated and cherished.  Her donation represents the initial funding that endorsed a local non-profit organization to continue its global work for almost three decades.

            SPOCCS —Shanxi Province Cervical Cancer Screening Study:  A Cross-Sectional Comparative Trial of Multiple Techniques to Detect Cervical Intraepithelial Neoplasia. Jerome L Belinson P.I. Funding Taussig Cancer Center and Multiple industries (including product from Digene Corporation) $268,000 1998-1999.

            Multiple small private donations, with special recognition to long term support and counsel from Mr. Anthony Yen (Cleveland, Ohio)

            SPOCCS II — Shanxi Province Cervical Cancer Screening Study II: A Comparative trial of Multiple Techniques to Detect Cervical Intraepithelial Neoplasia. Jerome L. BelinsonP.I. Funding Molecular Diagnostics Inc., and P.O.I., $876,071.17   0ct. 2000-June 2002. (IRB- 3822)

            MECCS Pilot –Mexican Cervical Cancer Screening Study–Pilot, Jerome L. Belinson P.I.-Funding P.O.I., and “Test for Life Fund” Morelia, Mexico.  Budget- $185,358. (IRB- 4760).

            MECCS I —- Mexican Cervical Cancer Screening Study. Jerome L. Belinson P.I.- Rotary International -$90,000, 2001-2004.

            OCT –Study of the Diagnostic Efficacy of Optical Coherence Tomography in the Management of Pre- invasive and Invasive Cancer of the Uterine Cervix and the Vulva. Funding from Imalux Corp. $36,000, Jerome L. Belinson P.I. (IRB- 4935)

            E2 — Multicenter Clinical Study Assessing the Equivalence of the InPath e2 Cervical Cell Collector to a Standard Endocervical Brush in a Patient Population Including Both Patients with a Recent “normal” Pap Screening Diagnosis and Patients Returning for Colposcopy/Biopsy, $82,000,Jerome L. Belinson P.I. (IRB- 4211).

            CVX – Multicenter Study of the Inpath CVX –Assay (Molecular Biomarker) in the Diagnosis of Pre-Invasive Carcinoma of the Uterine Cervix. Funding Molecular Diagnostics Inc. $82,608. Jerome L. Belinson P.I.  (IRB- 4793) In addition a laboratory is being established at Edison Biotec to allow further expansion of our Ovarian as well as our Cervical Cancer early diagnosis work.

            Survey – Women’s Experience with the self-test for HPV – A Questionnaire Investigating the Understanding of Cervical Cancer, HPV, and Cultural Differences in Acceptance of self-testing; P.I. Suzanne E. Belinson MPH, Co-investigator JL Belinson.  Funding from Preventive Oncology International $10,000. (Component IRB-3822).

            Development of Optical Coherence Tomography for the Management of Pre-invasive and Invasive Cancers of the Cervix and Vulva. Ohio Technology Action Fund $542,000 Granted with Matching Funds of $271,000 from Investors of Imalux Corporation. Jerome L. Belinson P.I. (July 2002).

            NIH Contract – Pilot evaluating self-collection devices for HPV testing.  JL Belinson (March 2006) $24,975.00.

            SPOCCS III – Detection of a Broad Spectrum of HPV Types and Associated Cervical Cancer and Intraepithelial Neoplasia in Chinese Women Between the Ages of 15 and 55 in 5 Sites in China: A Community Based Epidemiologic Study. JL Belinson P.I. Funding Merck $1,450,000.00 and Preventive Oncology International $111,830.26

            PUSH-OCT and GUIZHOU OCT – “Study of the diagnostic efficacy of “real time” optical coherence tomography (oct) in the management of pre-invasive and invasive neoplasia of the uterine cervix”  and “study of the diagnostic efficacy of “real-time” optical coherence tomography (OCT) as an adjunct to unaided visual inspection with acetic acid (v) for the diagnosis of pre-invasive and invasive neoplasia of the uterine cervix” $50,000  and $65,000  respectively, 2005-2008 Imalux Corporation. JL Belinson PI

            MECCS II – Mexican Cervical Cancer Screening Study II – Funding $450,000 from Gen-Probe Inc., additional support from the Secretary of Health State of Michoacan, Mexico, Qiagen Corporation, and Preventive Oncology International Inc, and the Cleveland Clinic. JL Belinson PI 2009-2010

            MECCS II Follow-up — $25,000 – Preventive Oncology International, Inc. 2009-2010

            SHENCCAST I – The Shenzhen Cervical Cancer Screening Trial I, 2008-2009, funding from Ministry of Health Shenzhen China, TriPath Inc., and $130,000 from Gen-Probe Inc., Beijing Genomics Institute. PI Ruifang Wu , JL Belinson Co-PI

            SHENCCAST II – The Shenzhen Cervical Cancer Screening Trial II, 2009-2010. Funding $1,500,000 from Hologic Inc. additional support Shenzhen Female Doctors Association, Preventive Oncology International, Inc., Beijing Genomics Institute.   JL Belinson PI

            SHENCCAST III – Unrestricted Grant from Hologic Inc. – Applied to an Evaluation of Cervista 16/18 HPV Assay – $460,650.00 JL Belinson PI.  Jan 2011.

            PERCAPS – The Development of a “Mother/Child. Screen, Treat and Vaccinate Program” in Diverse High Risk Environments in Peru. Merck Inc. Investigator Initiated Studies Program. $426,919 .00 JL Belinson PI, Feb. 2011

            CHICAPS – CHINESE CANCER PREVENTION STUDY (CHICAPS)

Mass Population Based Cervical Cancer Screening with an Algorithm Based on Self-

Sampling for Type Specific High-Risk HPV Using a Community Based Participatory Research Model.   A Collaborative Project under Preventive Oncology International, Peking University Shenzhen Hospital & BGI Shenzhen. Total shared budget – $1,083,316.42   Belinson PI, Wu Co-PI, 2010-2012.

            CHIMUST – Shenzhen Municipal Science and Technical Innovation Committee (No. JCYJ20120619145419556). Chinese Multi-site Screening Trial. 2015 Belinson Co-PI. 10,000,000 RMB.

            Shanxi Dayi International Research – 1,000,000 RMB 2017, 2018

Warm thanks go out to all who helped fund our research but were not included in this list.

Below is a (not so brief) list of publications that have directly resulted from, or used data from POI research.

  1. Yang L, Zhang WH, Pan QJ, Li L, Rong SD, Belinson JL, Pretorius RG, Qiao YL.  A pilot study for cervical cancer screening trials in Shanxi Province. Bulletin of Chinese Cancer 2000;9(9): 391-392 (Article in Chinese).
  2. Yang L, Qiao YL, Li N, Zhang X, Kong, LH, Rong SD, Ma JF, Belinson J. Synthesis and cluster analysis for multiple screening techniques for cervical cancer. Cancer Research on Prevention and Treatment 2001;28(4):253-255 (Article in Chinese).
  3. Zhao FH, Li N, Ma JF, Zhang X, Wu LY, Rong SD, Lorincz A, Belinson JL, Qiao YL. Study of the association between human papillomavirus infection and cervical cancer in Xiangyuan County, Shanxi Province. Chin J Epidemiol., October 2001; 22(5):375-378 (Article in Chinese).