Cervical Intraepithelial NeoplasiaCHICAPSNCT01524003
Chinese Cancer Prevention Study(CHICAPS)
A study testing cryotherapy and Colposcopy in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Preventive Oncology International, Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Neoplasm
- What is being tested?
- cryotherapy and Colposcopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,382 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non pregnant women 35-59 years of age.
- No hysterectomy
- No prior pelvic radiation.
- Willing to sign consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chinese Cancer Prevention Study(CHICAPS) Mass Population Based Cervical Cancer Screening
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.
Read the 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
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Neoplasm, Cervical Dysplasia, Human Papillomavirus
- Being tested
- cryotherapy, Colposcopy
- Keywords
- community based participatory research
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
Also called MedGyn cryotherapy, medical grade CO2
cryotherapy treatment of the uterine cervix
ColposcopyProcedure or surgery
Also called Digital colposcopy, POI microbiopsy, LEEP
Colposcopy, biopsy and LEEP based on the pathology results
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
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
Measured: Ongoing for up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Preventive Oncology International, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Responsible party
- Sponsor
- Investigators
- Jerome L Belinson, MD, Principal investigator, Preventive Oncology InternationalRufiang Wu, MD, Principal investigator, Peking Universtiy Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524003
- Sponsor's protocol ID
- CHICAPS
- Acronym
- CHICAPS
- Status last verified
- May 2015
- First submitted
- 29 Dec 2011
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24440471
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Cancer Prevention Study(CHICAPS) Mass Population Based Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT01524003
- Acronym / sponsor ID
- CHICAPS / CHICAPS
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Neoplasm, Cervical Dysplasia, Human Papillomavirus
- Keywords
- community based participatory research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,382 participants (actual)
- Lead sponsor
- Preventive Oncology International, Inc.University, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy after VIA triage | Experimental | Procedure: cryotherapyWomen 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. |
| Colposcopy and biopsy | Active comparator | Procedure: ColposcopyStandard 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. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non pregnant women 35-59 years of age.
- No hysterectomy
- No prior pelvic radiation.
- Willing to sign consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapyAlso: MedGyn cryotherapy, medical grade CO2cryotherapy treatment of the uterine cervix | Procedure or surgery | Cryotherapy after VIA triage |
| ColposcopyAlso: Digital colposcopy, POI microbiopsy, LEEPColposcopy, biopsy and LEEP based on the pathology results | Procedure or surgery | Colposcopy and biopsy |
Primary outcome
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
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
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
1 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.
Time frame: Ongoing for up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Derived from this study: PubMed 24440471Belinson 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.
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Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome L Belinson, MD principal investigator
Preventive Oncology International
Rufiang Wu, MD principal investigator
Peking Universtiy Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy and Colposcopy in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Preventive Oncology International, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.