Uterine Cervical CancerNCT06491888
A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening
A study testing Detection of Cervical Lesions by Fluorescence Photoelectric Image in people with Uterine Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Lei Li at 1 site in China.
Trial summary
The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Cervical Cancer, Cervical Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Lesions
- What is being tested?
- Detection of Cervical Lesions by Fluorescence Photoelectric Image
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2024to Jul 2025
- 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
- 1. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
- 2. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
- 3. Fully informed and agreed to participate in the study.
- 4. No history of cervical cancer disease and cancer in other parts.
Who cannot join
- 1. Cannot meet all Inclusion Criteria.
- 2. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
- 3. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening
The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.
The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.
In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.
- Conditions
- Uterine Cervical Cancer, Cervical Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions
- Being tested
- Detection of Cervical Lesions by Fluorescence Photoelectric Image
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Cervical Lesions by Fluorescence Photoelectric ImageDiagnostic test
Photoelectric detection was carried out on the subjects of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Group Accepting Photoelectric Detection | Experimental | The subjects in this group need to undergo the detection of fluorescence photoelectric cervical lesion image detector before colposcopy, and then undergo routine colposcopy and biopsy after the detection. Receives: Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image |
| Routine colposcopy group | No intervention | Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.
Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings.
Measured: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector.
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared between the fluorescence photoelectric technology and HPV detection results and cytology results, and the consistency and coincidence between the fluorescence photoelectric technology and HPV detection results and cytology results were calculated.
Measured: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Secondary outcomes (1)
The correlation between fluorescence photoelectric technology and HPV detection and cytology results.
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of 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 posted9 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491888
- Sponsor's protocol ID
- OITS2
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT06491888
- Acronym / sponsor ID
- OITS2
- Conditions
- Uterine Cervical Cancer, Cervical Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Jul 2024 (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 main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.
The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.
In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Accepting Photoelectric Detection | Experimental | Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric ImageThe subjects in this group need to undergo the detection of fluorescence photoelectric cervical lesion image detector before colposcopy, and then undergo routine colposcopy and biopsy after the detection. |
| Routine colposcopy group | No intervention | –Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
- 2. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
- 3. Fully informed and agreed to participate in the study.
- 4. No history of cervical cancer disease and cancer in other parts.
Key exclusion criteria (3 listed)
- 1. Cannot meet all Inclusion Criteria.
- 2. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
- 3. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
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 |
|---|---|---|
| Detection of Cervical Lesions by Fluorescence Photoelectric ImagePhotoelectric detection was carried out on the subjects of the experimental group. | Diagnostic test | Group Accepting Photoelectric Detection |
Primary outcome
Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings.
Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared between the fluorescence photoelectric technology and HPV detection results and cytology results, and the consistency and coincidence between the fluorescence photoelectric technology and HPV detection results and cytology results were calculated.
1 secondary outcome
The correlation between fluorescence photoelectric technology and HPV detection and cytology results.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of Cervical Lesions by Fluorescence Photoelectric Image in people with Uterine Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Lei Li 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 3 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 15 Aug 2024. 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 Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions. (time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.). 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 15 Aug 2024.