An interventional study of Detection of Cervical Lesions by Fluorescence Photoelectric Image in Uterine Cervical Cancer, Cervical Intraepithelial Neoplasia and High Grade Squamous Intraepithelial Lesions, sponsored by Lei Li. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Lei Li · Not applicable, Interventional, and Screening
Among 23 studies in Uterine Cervical Neoplasms by Lei Li — 5 open to participants now, 5 under way, none of them phase 3. Uterine Cervical Neoplasms · Lei Li.
Among the 23 studies in Uterine Cervical Neoplasms by Lei Li, this one is the 2nd largest by planned enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2024, is the only one with no phase, and was the 22nd registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →5 of the 23 studies in Uterine Cervical Neoplasms by Lei Li are open now, in 1 country. Recruiting first, the newest first:
Lei Li · Sites in China
Lei Li · Sites in China
Lei Li · Sites in China
Lei Li · Sites in China
By country, each count listing its studies:
Of the 473 Uterine Cervical Neoplasms studies recruiting now, 242 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2024.
This study's planned enrollment of 4,200 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 59 across the 12 interventional studies, 5,000 across the 11 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Lei Li is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Uterine Cervical Neoplasms by Lei Li, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image
Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure.
Photoelectric detection was carried out on the subjects of the experimental group.
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.
Time frame: 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.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
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.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Start is estimated for Aug 2024; primary completion for Jul 2025, 11 months later.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 11 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Lei Li