Cervical Intraepithelial NeoplasiaHPVNCT03436251
Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias
A study testing Local Hyperthermia at 37℃, LEEP or cold knife and Local Hyperthermia at 44℃ in people with Cervical Intraepithelial Neoplasia and Human Papilloma Virus, run by First Hospital of China Medical University at 1 site in China.
Trial summary
Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Human Papilloma Virus
- What is being tested?
- Local Hyperthermia at 37℃, LEEP or cold knife and Local Hyperthermia at 44℃
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2018to 1 Aug 2020
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV; Cervical biopsy CIN or no cytological changes; signed informed consent
Who cannot join
- Pregnant woman;local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses； no guarantee of timely treatment and follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial
Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required.
Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions.
Read the detailed description
Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions. One control arm is local hyperthermia at 37°C for 30 mins targeted for CINⅠ, the other control arm is LEEP targeted for CINⅡ. After 3 months, to evaluate the effectivity of local hyperthermia.
- Being tested
- Local Hyperthermia at 37℃, LEEP or cold knife, Local Hyperthermia at 44℃
- Keywords
- hyperthermia, human papillomavirus virus, cervical intraepithelial neoplasia
- Medical subject headings
- Uterine Cervical Dysplasia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Hyperthermia at 37℃Device
As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied
LEEP or cold knifeDevice
For patients with HPV+ / CIN-2
Local Hyperthermia at 44℃Device
As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology
| Study group | Role | What they receive |
|---|---|---|
| Local Hyperthermia at 44℃ for HPV+/CIN-1 | Experimental | Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18. HPV+ and normal cytology or HPV+/CIN-1 Receives: Device: Local Hyperthermia at 44℃ |
| local hyperthermia at 37℃ for 30 mins | Sham comparator | HPV+/CIN-1 Receives: Device: Local Hyperthermia at 37℃ |
| coniztion of the cervix treatment | Active comparator | coniztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion Receives: Device: LEEP or cold knife |
| Local Hyperthermia at 44℃ for CIN2/HPV+ | Experimental | Local hyperthermia at 44℃ for 30 mins at days of 1,2,3 and 17, 18. HPV+ and CIN2. Receives: Device: Local Hyperthermia at 44℃ |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance rates of HPV
to evaluate the clearance rates in different treatment groups 3 month after treatment.
Measured: 3 months after the last time of treatment.
scoring atypia by cytology/pathology
to evaluate atypia severity score of cervical cells 3 month after treatment.
Measured: 3 months after the last time of treatment.
Secondary outcomes (1)
viral load measurement
to measure the HPV 16 viral load after 3 month of treatment
Measured: 3 months after the last time of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start28 Jan 2018
- Primary completion8 May 2020
- Study completion1 Aug 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
- Investigators
- Xinghua Gao, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436251
- Sponsor's protocol ID
- HH20170606
- Acronym
- HPV
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2017
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Zhang L, Zhang Y, Huo W, Qi R, Guo H, Li X, Wu X, Bai F, Liu K, Qiao Y, Piguet V, Croitoru D, Chen HD, Gao XH. Local Hyperthermia at 44 degrees C Is Effective in Clearing Cervical High-Risk Human Papillomaviruses: A Proof-of-Concept, Randomized Controlled Clinical Trial. Clin Infect Dis. 2021 Nov 2;73(9):1642-1649. doi: 10.1093/cid/ciab369.
PubMed 33905482
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03436251
- Acronym / sponsor ID
- HPV / HH20170606
- Keywords
- hyperthermia, human papillomavirus virus, cervical intraepithelial neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required.
Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions.
Detailed description
Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions. One control arm is local hyperthermia at 37°C for 30 mins targeted for CINⅠ, the other control arm is LEEP targeted for CINⅡ. After 3 months, to evaluate the effectivity of local hyperthermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local Hyperthermia at 44℃ for HPV+/CIN-1 | Experimental | Device: Local Hyperthermia at 44℃Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18. HPV+ and normal cytology or HPV+/CIN-1 |
| local hyperthermia at 37℃ for 30 mins | Sham comparator | Device: Local Hyperthermia at 37℃HPV+/CIN-1 |
| coniztion of the cervix treatment | Active comparator | Device: LEEP or cold knifeconiztion of cervix for HPV+/CIN2, including LEEP or cold knife coniztion |
| Local Hyperthermia at 44℃ for CIN2/HPV+ | Experimental | Device: Local Hyperthermia at 44℃Local hyperthermia at 44℃ for 30 mins at days of 1,2,3 and 17, 18. HPV+ and CIN2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV; Cervical biopsy CIN or no cytological changes; signed informed consent
Key exclusion criteria (1 listed)
- Pregnant woman;local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses； no guarantee of timely treatment and follow-up
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 |
|---|---|---|
| Local Hyperthermia at 37℃As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied | Device | local hyperthermia at 37℃ for 30 mins |
| LEEP or cold knifeFor patients with HPV+ / CIN-2 | Device | coniztion of the cervix treatment |
| Local Hyperthermia at 44℃As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology | Device | Local Hyperthermia at 44℃ for CIN2/HPV+, Local Hyperthermia at 44℃ for HPV+/CIN-1 |
Primary outcome
clearance rates of HPV
Time frame: 3 months after the last time of treatment.
to evaluate the clearance rates in different treatment groups 3 month after treatment.
scoring atypia by cytology/pathology
Time frame: 3 months after the last time of treatment.
to evaluate atypia severity score of cervical cells 3 month after treatment.
1 secondary outcome
viral load measurement
Time frame: 3 months after the last time of treatment.
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 18 Aug 2021.
- Derived from this study: PubMed 33905482Yang Y, Zhang L, Zhang Y, Huo W, Qi R, Guo H, Li X, Wu X, Bai F, Liu K, Qiao Y, Piguet V, Croitoru D, Chen HD, Gao XH. Local Hyperthermia at 44 degrees C Is Effective in Clearing Cervical High-Risk Human Papillomaviruses: A Proof-of-Concept, Randomized Controlled Clinical Trial. Clin Infect Dis. 2021 Nov 2;73(9):1642-1649. doi: 10.1093/cid/ciab369.
- Individual participant dataSharing planned: No
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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.
Xinghua Gao study director
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Hyperthermia at 37℃, LEEP or cold knife and Local Hyperthermia at 44℃ in people with Cervical Intraepithelial Neoplasia and Human Papilloma Virus, run by First Hospital of China Medical University 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 1 inclusion and 1 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 18 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
clearance rates of HPV (time frame: 3 months after the last time of treatment.). 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 NCT03436251, 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 18 Aug 2021.