Chinese Cancer Prevention Study(CHICAPS)
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Cervical Neoplasm; Cervical Dysplasia; Human Papillomavirus
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): cryotherapy; Colposcopy
Intervention type(s): Procedure; Procedure
Intervention description(s): cryotherapy treatment of the uterine cervix; Colposcopy, biopsy and LEEP based on the pathology results
Other intervention name(s): MedGyn cryotherapy; medical grade CO2; Digital colposcopy; POI microbiopsy; LEEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: community based participatory research