HPV IntegrationNCT05300243
The Predictive Role of HPV Integration in HSIL and Cervical Cancer
An observational study of HPV Integration, run by Tongji Hospital at 1 site in China.
Trial summary
The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Integration
- What is being tested?
- HPV integration test
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2020to 1 Jun 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is expected to be included in 2000 female in this study.
Who may be able to join
- HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.
Who cannot join
- Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 350000
Shuang Li, +8618971625668, shuangli@hust.edu.cn
About this study
The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.
- Conditions
- HPV Integration
- Being tested
- HPV integration test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV integration testDiagnostic test
The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue pathological diagnosis
Tissue pathological diagnosis in 1 year since HPV integrated test
Measured: 1year since HPV integrated test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start7 Jul 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV IntegrationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuang Li, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300243
- Sponsor's protocol ID
- 2021-S140
- Status last verified
- Jul 2021
- First submitted
- 3 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Role of HPV Integration in HSIL and Cervical Cancer
- ClinicalTrials.gov ID
- NCT05300243
- Acronym / sponsor ID
- 2021-S140
- Conditions
- HPV Integration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 29 Mar 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.
The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is expected to be included in 2000 female in this study.
Key inclusion criteria (1 listed)
- HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.
Key exclusion criteria (1 listed)
- Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.
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 |
|---|---|---|
| HPV integration testThe stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening. | Diagnostic test | – |
Primary outcome
Tissue pathological diagnosis
Time frame: 1year since HPV integrated test
Tissue pathological diagnosis in 1 year since HPV integrated test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for HPV Integration
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Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
Human Papilloma Virus Infection, Human Papilloma Virus Integration
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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.
Shuang Li 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?
An observational study of HPV 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 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuang Li, PHD (+86 18971625668, shuangli@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue pathological diagnosis (time frame: 1year since HPV integrated test). 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 29 Mar 2022.