OVERALL MISSION:

OBJECTIVES OF CURRENT PROJECTS

1. To develop and trial low-cost screening algorithms for the detection of pre-invasive disease of the uterine cervix in underserved areas of the world.
2. To develop and trial screening technologies that will reach the underserved in all parts of the world including those who remain outside established healthcare systems.
3. To provide cost and time efficient research programs that are able to provide vital clinical research data for industries with technologies related to cancer prevention and early diagnosis.
4. To teach the low-cost screening and diagnostic algorithms so they may continue in these underserved areas when demonstrated to be successful.
5. To provide experiences in international public health for students, residents, fellows and other interested physicians.

During POI’s first decade the focus has been on cervical cancer prevention due in part to the opportunities that existed, and the expertise of the founding members. As we look towards the future we will expand our activities and investigate preventive and early diagnostic strategies for other primary organ sites.

Mortality from cervical cancer is uncommon in developed countries. In 1989 in the United States, mortality from cervical cancer was only 3.1 per 100,000 women per year. In part, the low mortality from cervical cancer can be attributed to early detection of and elimination of precancers. In developed countries this has been realized by periodic cytologic screening with Papanicolaou smears. Theoretically, periodic cytologic screening can prevent 90% of invasive squamous cancers of the cervix.

The remarkable decline in mortality from cervical cancer seen in developed countries has not been seen in underdeveloped countries. Worldwide, cervical cancer remains the second most common malignancy in both incidence and mortality, with close to a half a million cases diagnosed, and 230,000 deaths each year. It is the greatest cause of death from cancer in women in the developing world and the greatest cancer killer of young women (< age 50). It kills women at the height of their productive lives often when they still have children at home. Though periodic cytologic screening could decrease these numbers greatly, it has not been adopted worldwide because it is expensive and because a cytology based screening system requires a significant healthcare infrastructure.

To limit expense and the need for a complex healthcare infrastructure, we have been studying various screening technologies looking to find combinations or single tests that are sensitive and specific enough such that women who test positive can be treated for precancer of the cervix without resorting to histologic (biopsy) confirmation of the diagnosis.

Our original work was a controlled study that, for the first time, directly measured sensitivity and specificity of five cervical cancer screening technologies. In October of 1998 we conducted a pilot study in Xiangyuan and Yangcheng Counties in Southwest Shanxi Province, Peoples Republic of China. We demonstrated a high prevalence of cervical neoplasia as well as the feasibility of a large cross-sectional comparative trial of multiple screening techniques. A report of this trial has been published in the International Journal of Gynecologic Cancer. In the summer of 1999, a full clinical trial was completed (the Shanxi Province Cervical Cancer Screening Study – SPOCCS). Two thousand women between 35 and 45 years of age from Xiangyuan County were recruited by a field supervisor from the Department of Epidemiology of the Cancer Institute/Hospital of the Chinese Academy of Medical Sciences in Beijing and the local commune nurse (much like our LPN’S, often referred to as “Barefoot Doctors”). The fact that at least five cervical biopsies were obtained on every participant in the trial using special biopsy instruments (even those who had negative screening tests and negative colposcopy ) allowed us to directly measure the sensitivity and specificity of the screening tests. (POI micro-biopsy protocol below)

Data from the full screening study performed in the summer of 1999 was published by Gynecologic Oncology. In April of 2000 our research team received the first prize award for our work at Eurogin 2000 in Paris. This meeting which takes place every two years brings together many of the groups and individuals world-wide working on cervical cancer. Manuscripts on visual inspection techniques for screening, HPV testing, self-sampling, colposcopy, and liquid based pap test technology have also been published by POI. On the basis of the data from our work in SPOCCS , we began a 9000 patient trial in rural China (SPOCCS II) studying a new bio-molecular marker for diagnosing pre-invasive disease and continuing our work with self-sampling technology. In 2006 we completed a study of almost 8500 women in the State of Michoacán, Mexico. This study (MECCS) applied some of our previous findings to demonstrate that the prevalence of high-grade pre-invasive disease can be significantly decreased by a low cost algorithm tailored to the available infrastructure in rural Mexico. This program used self-sampling for the high-risk types of the human papillomavirus (the necessary cause of cervical cancer) to address and overcome many of the barriers to effective cervical cancer screening in Mexico. Unmagnified visual inspection was investigated as a secondary screen. In addition we have developed, and tested a survey instrument that explores cross-cultural differences in women’s acceptance of self-sampling technology.

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