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

35 Years
59 Years
Open (Enrolling)
Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Neoplasm, Cervical Dysplasia, Human Papillomavirus

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Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Ongoing for up to 36 months

Safety Issue:


Principal Investigator

Jerome L Belinson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Preventive Oncology International


China: Ethics Committee

Study ID:




Start Date:

November 2011

Completion Date:

August 2014

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Cervical Neoplasm
  • Cervical Dysplasia
  • Human Papillomavirus
  • community based participatory research
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ