Screening for cervical cancer Cancer
Conditions
Interventions
All participants provided a cervical sample for HPV and WID-qCIN DNA methylation testing, underwent cytology, colposcopy, and biopsy for histological confirmation. No therapeutic intervention was admi
Sponsors
University College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 25–65 years 2. Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Current pregnancy. 2. History of hysterectomy, cervical or endometrial cancer, or pelvic radiotherapy. 3. Treatment for cervical intraepithelial neoplasia (CIN) within the preceeding six months. 4. Participants receiving ablative treatment at the time of colposcopy (precluding histological sampling).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the WID-qCIN DNA methylation test for the detection of CIN3+, using histologically confirmed CIN3 or invasive cervical cancer as the reference standard. Measured via cytology analysis and colposcopic assessment conducted at baseline. Diagnostic performance will be assessed using sensitivity and specificity following completion of laboratory analysis for all participant samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy (sensitivity and specificity) of cytology and colposcopy for the detection of CIN3+, compared with histology as the reference standard. Measured via cytology analysis and colposcopic assessment conducted at baseline. Diagnostic performance will be assessed using sensitivity and specificity following completion of laboratory analysis for all participant samples. 2. Diagnostic accuracy (sensitivity and specificity) of HPV 16/18 and the composite WID-qCIN/HPV 16/18 test for the detection of CIN3+, compared with histology as the reference standard. Measured via HPV genotyping and WID-qCIN DNA methylation testing on participant samples collected at baseline. Diagnostic performance will be assessed using sensitivity and specificity following completion of laboratory analysis for all participant samples. 3. Comparative performance of WID-qCIN vs cytology and colposcopy as triage tools in hrHPV- positive women. Measured as sensitivity and specificity with 95% confidence intervals following completion of laboratory analysis on all participant samples. 4. Distribution of hrHPV subtypes in the study population. Measured via HPV genotype testing on participant samples collected at baseline. | — |
Countries
Nigeria
Contacts
Public ContactOjone Illah
Outcome results
None listed