An observational study in Uterine Cervical Cancer, High Grade Squamous Intraepithelial Lesions and Low 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 2024-07-03.
Sponsored by Lei Li · Observational
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 11 observational ones that give a count, is one of 3 that started in 2024, is one of 11 observational ones, and was the 21st 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 20,000 is above the median of 225 across 529 observational 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 explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.
This study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.
This is a multicenter, parallel controlled, cross-sectional real-world study based on the population of a hospital gynecology clinic (gynecology clinic/colposcopy room).
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 enrolled patients were detected with fluorescence photoelectric cervical lesion image detector.
Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image
The enrolled patients underwent fluorescence photoelectric cervical lesion image detection, followed by colposcopy and biopsy to obtain histopathological results. The results of fluorescence photoelectric image detection were compared with histopathological results, and at the same time compared with HPV and TCT results at the time of enrollment.
Accuracy of tissue lesion screening based on photoelectric detection
The sensitivity, specificity, positive predictive value and negative predictive value of fluorescence photoelectric cervix lesion image detector were calculated by using CIN 2 + as the gold standard determined by histopathology, and compared with those of HPV and TCT.
Time frame: The data collection time for each subject is approximately 7 days, starting from the day of each subject's enrollment and ending when the pathology report of the cervical tissue biopsy under colposcopy is issued.
Start is estimated for Jul 2024; primary completion for Jul 2026, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Lei Li