Cervical CancerCC-AZNCT06866392
Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection and Epigenetic Procotol
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Peking Union Medical College Hospital.
Trial summary
A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia
- What is being tested?
- photoelectric detection
- How many people
- 4,200 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Mar 2028
- Phase
- Observational
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: There are 30 multi-center units in the country, and each center competes to enter the group. The accuracy of OITS early data was 75%, the sensitivity was 82%, and the specificity was 63%. According to 20% shedding, possible causes of shedding: error caused by severe inflammatory patients, error caused by improper operation or subjects unwilling to cooperate with follow-up. The optimal efficacy test was performed with the rate of 0.75 in the experimental group and 0.5 in the control group, and the optimal efficacy threshold was 0.1(control-experimental group), bilateral alpha was 0.05, beta was 0.2, and the sample size ratio of the two groups was 1(experimental group: Control group), each single center needs to collect 58 cases in the experimental group and 58 cases in the control group. Considering 20% shedding, the sample size of each single center is at least 70 cases in the experimental group and 70 cases in the control group, and a total of 4200 cases of all centers.
Who may be able to join
- Women between the ages of 18 and 65 who have already had sex life
- HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
- No history of cervical cancer and cervical physical therapy, a complete cervix
- No menstrual period, no sexual activity and vaginal medication within 48 hours
- The vagina or cervix is not in a stage of acute inflammation
- Willing to participate in the study with full informed consent
Who cannot join
- Cervical dysplasia (congenital malformation or double uterus, etc.)
- History of cervical treatment (coning, ablation, or photodynamic therapy)
- There are definite immunosuppression conditions, such as HIV infection or organ transplantation
- Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)
- A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites
- The patient is in pregnancy or puerperium
- The other conditions of this study were not considered appropriate by the researchers
About this study
Official title: Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol
A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.
- Being tested
- photoelectric detection
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photoelectric detectionDiagnostic test
Methylation test and colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test and colposcopic biopsy and OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results.
| Study group | Role | What they receive |
|---|---|---|
| control group | Methylation test and colposcopic biopsy, and clinical follow-up based on methylation results | |
| OITS group | The experimental group underwent methylation test and colposcopic biopsy and OITS, and clinical follow-up was conducted according to methylation results and OITS results Receives: Diagnostic Test: photoelectric detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of a photoelectric image detector for cervical lesions
Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings.
Measured: Enrolled subjects receive histopathological results approximately 7 days after colposcopy
Secondary outcomes (1)
Detection rate of CIN2+ by photoelectric cervical lesion image detector
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of Methylaiton, colpscopy, HPV detection and cytology.
Measured: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866392
- Sponsor's protocol ID
- CCAZ
- Acronym
- CC-AZ
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol
- ClinicalTrials.gov ID
- NCT06866392
- Acronym / sponsor ID
- CC-AZ / CCAZ
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 10 Mar 2025 (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.
A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Methylation test and colposcopic biopsy, and clinical follow-up based on methylation results |
| OITS group | – | Diagnostic Test: photoelectric detectionThe experimental group underwent methylation test and colposcopic biopsy and OITS, and clinical follow-up was conducted according to methylation results and OITS results |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are 30 multi-center units in the country, and each center competes to enter the group. The accuracy of OITS early data was 75%, the sensitivity was 82%, and the specificity was 63%. According to 20% shedding, possible causes of shedding: error caused by severe inflammatory patients, error caused by improper operation or subjects unwilling to cooperate with follow-up. The optimal efficacy test was performed with the rate of 0.75 in the experimental group and 0.5 in the control group, and the optimal efficacy threshold was 0.1(control-experimental group), bilateral alpha was 0.05, beta was 0.2, and the sample size ratio of the two groups was 1(experimental group: Control group), each single center needs to collect 58 cases in the experimental group and 58 cases in the control group. Considering 20% shedding, the sample size of each single center is at least 70 cases in the experimental group and 70 cases in the control group, and a total of 4200 cases of all centers.
Key inclusion criteria (6 listed)
- Women between the ages of 18 and 65 who have already had sex life
- HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
- No history of cervical cancer and cervical physical therapy, a complete cervix
- No menstrual period, no sexual activity and vaginal medication within 48 hours
- The vagina or cervix is not in a stage of acute inflammation
Key exclusion criteria (7 listed)
- Cervical dysplasia (congenital malformation or double uterus, etc.)
- History of cervical treatment (coning, ablation, or photodynamic therapy)
- There are definite immunosuppression conditions, such as HIV infection or organ transplantation
- Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)
- A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites
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 |
|---|---|---|
| photoelectric detectionMethylation test and colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test and colposcopic biopsy and OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. | Diagnostic test | OITS group |
Primary outcome
Sensitivity and specificity of a photoelectric image detector for cervical lesions
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy
Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings.
1 secondary outcome
Detection rate of CIN2+ by photoelectric cervical lesion image detector
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
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 10 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Peking Union Medical College Hospital.
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 7 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Sensitivity and specificity of a photoelectric image detector for cervical lesions (time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy). 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 10 Mar 2025.