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Chinese Cancer Prevention Study(CHICAPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Peking University Shenzhen Hospital
Beijing Genomics Institute Shenzhen
Information provided by (Responsible Party):
Preventive Oncology International, Inc.
ClinicalTrials.gov Identifier:
NCT01524003
First received: December 29, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Cervical Intraepithelial Neoplasia
Cervical Cancer
Cervical Neoplasm
Cervical Dysplasia
Human Papillomavirus
Procedure: cryotherapy
Procedure: Colposcopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Chinese Cancer Prevention Study(CHICAPS) Mass Population Based Cervical Cancer Screening

Resource links provided by NLM:


Further study details as provided by Preventive Oncology International, Inc.:

Primary Outcome Measures:
  • The investigators will determine the percentage of the population in the target area that are reached by the screening protocol. [ Time Frame: Ongoing for up to 36 months ] [ Designated as safety issue: No ]
    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.

  • The investigators will determine the percentage of HPV screen positive women who return for evaluation and treatment. [ Time Frame: Ongoing for up to 36 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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. [ Time Frame: Ongoing for up to 36 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 10000
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
cryotherapy treatment of the uterine cervix
Other Names:
  • MedGyn cryotherapy
  • medical grade CO2
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
Colposcopy, biopsy and LEEP based on the pathology results
Other Names:
  • Digital colposcopy
  • POI microbiopsy
  • LEEP

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

  Eligibility

Ages Eligible for Study:   35 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524003

Locations
China, Guangdong
HeShan Public Health Department
Jiangmen Municipal City, Guangdong, China
Sponsors and Collaborators
Preventive Oncology International, Inc.
Peking University Shenzhen Hospital
Beijing Genomics Institute Shenzhen
Investigators
Principal Investigator: Jerome L Belinson, MD Preventive Oncology International
Principal Investigator: Rufiang Wu, MD Peking Universtiy Shenzhen Hospital
  More Information

No publications provided by Preventive Oncology International, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Preventive Oncology International, Inc.
ClinicalTrials.gov Identifier: NCT01524003     History of Changes
Other Study ID Numbers: CHICAPS
Study First Received: December 29, 2011
Last Updated: April 16, 2014
Health Authority: China: Ethics Committee
United States: Institutional Review Board

Keywords provided by Preventive Oncology International, Inc.:
community based participatory research

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014