Human Papilloma Virus InfectionNCT05510830
Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
A study testing diagnostic cervical conization in people with Human Papilloma Virus Infection and Human Papilloma Virus Integration, run by Tongji Hospital at 1 site in China.
Trial summary
For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Human Papilloma Virus Infection, Human Papilloma Virus Integration, Cervical Intraepithelial Neoplasia
- What is being tested?
- diagnostic cervical conization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Oct 2022to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.
- The cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors:
- The course of HPV type 16/18 persistent infection is more than two years.
- The integration reads of HPV is more than 15.
- The impression of colposcopy indicates precancerous lesions.
- The cervical TCT indicates ASC-H/HSIL/SCC/AGC-FN/AIS/AC.
Who cannot join
- Pregnant women.
- Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.
- The patients are suffering malignant tumors of other system and have not been cured.
- There is acute inflammation of the lower genital or anal tract.
- The patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 350000
About this study
Official title: A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus
For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.
Read the detailed description
For the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. As the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. In this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.
- Conditions
- Human Papilloma Virus Infection, Human Papilloma Virus Integration, Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Conization
- Being tested
- diagnostic cervical conization
- Keywords
- HPV persistent infection, HPV integration, diagnostic cervical conization
- Medical subject headings
- Papillomavirus Infections, 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.
diagnostic cervical conizationProcedure or surgery
For the patients who met the inclusion criteria, the gynecologists perform cervical conization and pathological examinations. Then the patients will be followed-up for at least two years with the tests of cervical TCT \& HPV, and colposcopy if necessary. The data will be analyzed and see if the patients with high risk factors benefit from the surgery or not.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | The patients who meet the inclusion criteria will receive diagnostic cervical conization for pathological examinations. Then they will be followed up for at least two years with every six months' return to our clinics to test HPV and colposcopy if necessary. Receives: Procedure: diagnostic cervical conization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of discovering concealed cervical cancer or percancerous lesions
The pathological examinations of the cervical conization might discover some concealed cervical cancer or precancerous lesions which could not be discovered by biopsy guided by colposcopy.
Measured: up to 2 months after recruited
The incidence of HPV clearance after the cervical conization
After the cervical conizations, the patients will be arranged for follow-up every six months and HPV will be tested to see if the virus is cleared or not
Measured: Through the study completion, an average of 3~5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Li Shuang, Tongji Hospital
- Investigators
- Shuang Li, M.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510830
- Sponsor's protocol ID
- TJ-IRB20220769
- Status last verified
- Sep 2022
- First submitted
- 16 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Every six month, we will check if there is a new subject recruited in the study and update the data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Value of Diagnostic Cervical Conization for Persistent Infection or Integration of Human Papillomavirus
- ClinicalTrials.gov ID
- NCT05510830
- Acronym / sponsor ID
- TJ-IRB20220769
- Conditions
- Human Papilloma Virus Infection, Human Papilloma Virus Integration, Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Conization
- Keywords
- HPV persistent infection, HPV integration, diagnostic cervical conization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 22 Aug 2022 (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.
For the patients with cervical persistent infection or integration of HPV, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.
Detailed description
For the patients with cervical persistent infection or integration of human papillomavirus, the incidence of suffering cervical cancer or percancerous lesions increases. As the biopsy guided by colposcopy might miss some lesions, the cervical conization plays a role for the patients with high risk factors to diagnose the related cervical diseases. In this study, we has designed a program to perform cervical conization for certain patients to earlier and better diagnose and cure the diseases of HPV infection and related cervical intraepithelial neoplasia/cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: diagnostic cervical conizationThe patients who meet the inclusion criteria will receive diagnostic cervical conization for pathological examinations. Then they will be followed up for at least two years with every six months' return to our clinics to test HPV and colposcopy if necessary. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patients are referred to colposcopy and biopsy examinations due to abnormal cervical screening results with no precancerous lesions discovered by pathology.
- The cervical precancerous lesions are highly suspected by clinicians with one or more following risk factors:
Key exclusion criteria (5 listed)
- Pregnant women.
- Vaginal intraepithelial neoplasia is highly suspected by colposcopy and pathological examinations.
- The patients are suffering malignant tumors of other system and have not been cured.
- There is acute inflammation of the lower genital or anal tract.
- The patients' health will be severely harmed by the colposcopy and cervical conization due to some circumstances such as severe insufficiency of liver and kidney function, blood diseases and acute inflammation of other systems.
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 |
|---|---|---|
| diagnostic cervical conizationFor the patients who met the inclusion criteria, the gynecologists perform cervical conization and pathological examinations. Then the patients will be followed-up for at least two years with the tests of cervical TCT \& HPV, and colposcopy if necessary. The data will be analyzed and see if the patients with high risk factors benefit from the surgery or not. | Procedure or surgery | Patients |
Primary outcome
The incidence of discovering concealed cervical cancer or percancerous lesions
Time frame: up to 2 months after recruited
The pathological examinations of the cervical conization might discover some concealed cervical cancer or precancerous lesions which could not be discovered by biopsy guided by colposcopy.
The incidence of HPV clearance after the cervical conization
Time frame: Through the study completion, an average of 3~5 years
After the cervical conizations, the patients will be arranged for follow-up every six months and HPV will be tested to see if the virus is cleared or not
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Yes. Every six month, we will check if there is a new subject recruited in the study and update the data.
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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.
Shuang Li, M.D principal investigator
Tongji 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 diagnostic cervical conization in people with Human Papilloma Virus Infection and Human Papilloma Virus Integration, run by Tongji Hospital 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 6 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: opening soon, as of the sponsor's last update on 8 Sep 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Li, M.D (18971625668, lee5190008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of discovering concealed cervical cancer or percancerous lesions (time frame: up to 2 months after recruited). 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?
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 Sep 2022.