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Chinese Cancer Prevention Study(CHICAPS)

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赞助商
Preventive Oncology International, Inc.
合作者
Peking University Shenzhen Hospital

关键词

抽象

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.

描述

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

日期

最后验证: 04/30/2015
首次提交: 12/28/2011
提交的预估入学人数: 01/28/2012
首次发布: 01/31/2012
上次提交的更新: 05/05/2015
最近更新发布: 05/07/2015
实际学习开始日期: 10/31/2011
预计主要完成日期: 06/30/2013
预计完成日期: 12/31/2013

状况或疾病

Cervical Intraepithelial Neoplasia
Cervical Cancer
Cervical Neoplasm
Cervical Dysplasia
Human Papillomavirus

干预/治疗

Procedure: Cryotherapy after VIA triage

Procedure: Colposcopy and biopsy

-

手臂组

干预/治疗
Experimental: Cryotherapy after VIA triage
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.
Procedure: Cryotherapy after VIA triage
cryotherapy treatment of the uterine cervix
Active Comparator: Colposcopy and biopsy
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.
Procedure: Colposcopy and biopsy
Colposcopy, biopsy and LEEP based on the pathology results

资格标准

有资格学习的年龄 35 Years 至 35 Years
有资格学习的性别Female
接受健康志愿者
标准

Inclusion Criteria:

Inclusion Criteria

1. Non pregnant women 35-59 years of age.

2. No hysterectomy

3. No prior pelvic radiation.

4. Willing to sign consent form

Exclusion Criteria:

1. Males

2. Women younger than 35 years old and older than 59 years old.

3. Pregnant women.

4. Patients with known history of hysterectomy or radiation for a pelvic cancer.

5. Refusal to participate

结果

主要结果指标

1. The investigators will determine the percentage of the population in the target area that are reached by the screening protocol. [Ongoing for up to 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.

2. The investigators will determine the percentage of HPV screen positive women who return for evaluation and treatment. [Ongoing for up to 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

次要成果指标

1. The investigators will compare women treated in the standard of care arm and the experimental arm (VIA and cryotherapy) to determine the percentage of high grade disease at the 6 month follow-up and 2 year follow-up. [Ongoing for up to 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

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