Chinese Cancer Prevention Study(CHICAPS)

NCT01524003 | Completed

• 1 other identifier: CHICAPS
• Study Type: interventional
• Target: 8,382
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Cervical Neoplasm; Cervical Dysplasia; Human Papillomavirus

Keywords

community based participatory research

Outcome Measures

Primary Outcomes (2)

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

  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.

  Ongoing for up to 36 months

• The investigators will determine the percentage of HPV screen positive women who return for evaluation and treatment.

  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

  Ongoing for up to 36 months

Secondary Outcomes (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

Study Arms (2)

Cryotherapy after VIA triage

EXPERIMENTAL

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

Colposcopy and biopsy

ACTIVE COMPARATOR

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

Interventions

cryotherapy PROCEDURE

cryotherapy treatment of the uterine cervix

Also known as: MedGyn cryotherapy, medical grade CO2

Cryotherapy after VIA triage

Colposcopy PROCEDURE

Colposcopy, biopsy and LEEP based on the pathology results

Also known as: Digital colposcopy, POI microbiopsy, LEEP

Colposcopy and biopsy

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non pregnant women 35-59 years of age.
• No hysterectomy
• No prior pelvic radiation.
• Willing to sign consent form

You may not qualify if:

• Males
• Women younger than 35 years old and older than 59 years old.
• Pregnant women.
• Patients with known history of hysterectomy or radiation for a pelvic cancer.
• Refusal to participate

Sponsors & Collaborators

• Preventive Oncology International, Inc.: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

HeShan Public Health Department

Jiangmen Municipal City, Guangdong, China

Location

Related Publications (1)

• Belinson JL, Wang G, Qu X, Du H, Shen J, Xu J, Zhong L, Yi J, Yi X, Wu R. The development and evaluation of a community based model for cervical cancer screening based on self-sampling. Gynecol Oncol. 2014 Mar;132(3):636-42. doi: 10.1016/j.ygyno.2014.01.006. Epub 2014 Jan 14.

  PMID: 24440471 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Cryotherapy; Colposcopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jerome L Belinson, MD

  Preventive Oncology International

  PRINCIPAL INVESTIGATOR

• Rufiang Wu, MD

  Peking Universtiy Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: February 1, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

CN (1)