Chinese Cancer Prevention Study(CHICAPS)

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Brief Title

Chinese Cancer Prevention Study(CHICAPS)

Official Title

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

Brief 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
    


Study Type

Interventional


Primary Outcome

The investigators will determine the percentage of the population in the target area that are reached by the screening protocol.

Secondary Outcome

 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.

Condition

Cervical Intraepithelial Neoplasia

Intervention

cryotherapy

Study Arms / Comparison Groups

 Cryotherapy after VIA triage
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

8382

Start Date

November 2011

Completion Date

January 2014

Primary Completion Date

July 2013

Eligibility Criteria

        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
      

Gender

Female

Ages

35 Years - 59 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jerome L Belinson, MD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01524003

Organization ID

CHICAPS


Responsible Party

Sponsor

Study Sponsor

Preventive Oncology International, Inc.

Collaborators

 Peking University Shenzhen Hospital

Study Sponsor

Jerome L Belinson, MD, Principal Investigator, Preventive Oncology International


Verification Date

May 2015