An observational study in Cervical Cancer, DNA Methylation and Cytology, sponsored by Lei Li. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.
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 has the largest 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 23rd 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 and older · 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 30,000 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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Cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. Given the current limitations, such as the low specificity of human papillomavirus (HPV) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. This study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. Histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m), HPV testing, and cytological examinations. Furthermore, the study seeks to elucidate the relationship between DNA methylation levels and persistent HPV infection, while also assessing the applicability of PAX1m/JAM3m across diverse clinical settings. By focusing on alterations in DNA methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting PAX1m/JAM3m. The ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.
All women asking for cervical cancer screening in hospital situation or in community situationg
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:
PAX1m/JAM3m, with or without HPV testing and cytological pathology for cervical cancer screening
Also known as: HPV testing, cytological pathology
Number of participants with histopathological diagnosis of grade 2 cervical intraepithelial neoplasia (CIN) or worse (CIN2+)
Including CIN2, CIN3, adenocarcinoma in situ and invasive cervical carcinoma
Time frame: 1 year
Number of participants with histopathological diagnosis of grade 3 cervical intraepithelial neoplasia (CIN) or worse (CIN3+)
Including CIN3, adenocarcinoma in situ and invasive cervical carcinoma
Time frame: 1 year
Number of participants with histopathological diagnosis of invasive cervical carcinoma
Including invasive cervical carcinoma of various subtypes
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Oct 2026, 25 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 Aug 2024. You cannot join it, but the record below documents what was studied.
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Lei Li