Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Gardasil will be administered to 10-13 year old daughters and granddaughters of study participants according to manufacturers recommended schedule of administration. Gardasil is supplied as 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months.

DOSAGE FORMS AND STRENGTHS • 0.5-mL suspension for injection as a single-dose vial and prefilled syringe.

Gardasil

Jerome L Belinson, MD

Carlos Vallejos Sologuren, MD

This project will use a community based participatory research orientation to develop a model for large scale "campaign" preventive healthcare interventions. The investigators have considerable expertise with cervical cancer screening and HPV vaccination. The investigators also have well tested methodologies for cervical cancer screening that are highly effective, including self-sampling for HPV and improved specimen transport systems. Therefore, the investigators will use these medical interventions as the model preventive health interventions for this project.

Our research group has recently demonstrated that a self-collected cervico-vaginal sample tested with a very high throughput HR-HPV assay is as sensitive has a direct endocervical physician collected sample. Teamed with a non-liquid transport media the investigators believe the technology is solved to reach large populations in a short period of time. With the majority of the world's medically underserved now living in middle income countries it is not necessary to think simple and small to reach the Earth's needy. The investigators can think high tech and high throughput. The massive volumes possible, with proper organization, will control the per/patient cost. The investigators will think "events", not continuous care. Clearly continuous care is the only way to adequately provide the needed care for many problems. However, many interventions can be confined to events which organize large screening or vaccination days and only when positives are identified from the detection algorithm does the healthcare staff become involved for management. The investigators spend an enormous amount of resources identifying the majority of people who will ultimately test negative. The more local the paradigms and the more involved the community in designing the program, the greater will be the participation and the lost to follow-up segment will shrink. This mother, child, screen, treat and vaccinate program will use cervical cancer prevention as the target preventive healthcare intervention. Using community based research orientation the project will begin with a 3 day education program and collaborative meeting with the women leaders of the communities (promotoras). Collectively the investigators will develop the model for the community to advertise, educate, recruit, register, self-collect the specimens, deliver the samples, and report the results. In addition the logistics of the 3 vaccination schedule for the female children will be organized. The medical staff will be involved only with the management of the positives and the vaccine administration. The observational measures will focus on assessing how effectively each of the steps was accomplished.

The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru

The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)

The investigators will evaluate community participation, lost to follow up and potential sustainability. One on one interviews with participants will be conducted by trained medical staff. Additional measures to success will be gathered from interviews with promotoras, participating health services staff and recoeded observation. These analyses are descriptive in nature.

Peru Instituto Nacional de Enfermadades Neoplasticas (INEN)

Merck Sharp & Dohme LLC

Preventive Oncology International, Inc.

Jerome Belinson MD, president

Women who test HPV positive will be randomized to the experimental arm or the standard of care arm. In the Experimental arm VIA will be done to determine acceptability for cryotherapy \[R/O high-grade CIN too large for cryotherapy (usually 3-4 quadrant disease) or cancer\]. All acceptable patients will have an ECC done and then immediate cryotherapy.

Standard of care. Women testing positive for HPV will be randomized to the experimental arm (immediate cryotherapy) or the Standard of care arm, for colposcopy, biopsy, and leep based on the pathology results.

cryotherapy treatment of the uterine cervix

cryotherapy

Colposcopy, biopsy and LEEP based on the pathology results

Colposcopy

Rufiang Wu, MD

The purpose of this study is to develop and implement a community based preventive healthcare model using cervical cancer screening as the target medical intervention.

The investigators will first conduct 2 pilot studies to refine their preventive healthcare model based on the principles of community based participatory research (1000 participants). The investigators will then apply the model to screen 9000 women for cervical cancer over a period of 7-9 days. This 10,000 patient trial will explore the ability of a community to conduct their own screening program to identify who needs medical intervention based on self-collection and centralized high-throughput low cost human papillomavirus (HPV) testing.

Screening and prevention programs in general, throughout the world, suffer from major cost constraints, poor participation, lost to follow-up, and concerns about sustainability.

Over the past 15 years the investigators have been studying self-collection as a way to reach the medically underserved for cervical cancer screening. In a recent 10,000 patient randomized clinical trial they demonstrated that a self-collected sample is equivalent in accuracy to a physician obtained endocervical specimen and can be done less expensively and with higher throughput than all current and proposed accurate testing modalities.

With the majority of the worlds' medically underserved now living in middle income countries, it is no longer necessary to think small, slow, and simple, with poor quality control. It is totally achievable with self-collection to have centralized, high-throughput, low cost per case processing, and to reach millions of women in a short period of time. Again, these concepts need not be restricted to the medically underserved, but the clarity of this paradigm is a realistic solution for a critical developing world healthcare problem. In addition, we now have solid media specimen transport cards, thereby avoiding the logistics of dealing with personal use of alcohol-based liquids, concerns about exposure temperature, and ease of transportation. Using PCR-based technologies in a self-collection algorithm has the ability to not only make the testing highly sensitive, but help to address another key issue and that is how to manage the positives. In the investigators' proposed centralized model, since the primary output of the testing provides genotyping a reasonable option for tailoring the management of the positives would exist.

Now the need is to focus on developing the models that will enable them to efficiently place the existing technologies next to the women who need them the most. Developing community based systems that remove the identification of who is abnormal from the medical model, will markedly affect the cost of preventive healthcare. In addition with community involvement in the design of the program, it is expected that their participation in the "campaigns" and follow-up will be significantly improved. Sustainability also becomes a simpler problem because of the "campaign" or "event" type model (possibly once/year, or per every 5-10years). The investigators believe that the patient recruitment and loss to follow up observed in screening programs conducted in the developing world, have their roots in asking large numbers of patients, who are not presently ill, or symptomatic, to travel long distances and interrupt their daily life. The investigators believe that a much more effective program can be designed by the community, and using a self-collection model will ensure greater recruitment and participation, minimizing loss to follow up. This project CHICAPS is designed to further develop the community based screening model and in addition randomize treatment options to explore a technology more suited to rural environments

Chinese Cancer Prevention Study(CHICAPS)

Chinese Cancer Prevention Study(CHICAPS) Mass Population Based Cervical Cancer Screening

Pilot study will take up to 8 months. The community application will be complete approximately 5 months later and all follow up and data analysis will be complete in 36 months.

Pilot study will take up to 8 months. The community application will be complete approximately 5 months later and all follow up and data analysis will be complete in 36 months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru	NCT01338051	Cervical Intrae... Cervical Cancer Cervical Neopla... Cervical Dyspla... Human Papilloma...	Gardasil	30 Years - 45 Years	Preventive Oncology International, Inc.
Chinese Cancer Prevention Study(CHICAPS)	NCT01524003	Cervical Intrae... Cervical Cancer Cervical Neopla... Cervical Dyspla... Human Papilloma...	cryotherapy Colposcopy	35 Years - 59 Years	Preventive Oncology International, Inc.
Chinese Cancer Prevention Study(CHICAPS)	NCT01524003	Cervical Intrae... Cervical Cancer Cervical Neopla... Cervical Dyspla... Human Papilloma...	cryotherapy Colposcopy	35 Years - 59 Years	Preventive Oncology International, Inc.

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