Does Hr-HPV Status Influence the 2011 IFCPC Nomenclature and Swede Score's Capacity to Diagnose Precancerous Lesions?

Completed

• Conditions: Colposcopy; HPV; HSIL

• Registration Number: NCT07012356
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

Purpose: This study aims to examine the effectiveness of the Swede score and 2011 IFCPC Nomenclature in hr-HPV carriers and evaluate diagnostic sensitivity and specificity according to hr-HPV types and multiple HPV carrier status.

Methods: This study included 95 women with high-risk HPV. Colposcopic findings were scored using the Swede Score and the 2011 IFCPC system to predict pathology. Accuracy, sensitivity, specificity, PPV and NPV were calculated.

Detailed Description

This prospective study aims to examine the effect of 2011 IFCPC terminology, Swede score, and HPV type on the prediction of cervical precancerous lesions or cervical cancer in patients referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital between June 2024 and November 2024 for high-risk HPV carriers. An expert colposcopist evaluated all referred patients.

Sample size: a sample size of 95 has been determined using the formula n = \[(Zα)2 × p(1 - p)\] / e2, with allowable error of 7%, and p value = 0.781, derived from the study done by Shojaei et al.

n = \[(1.645)2 × 0.781(1-0.781)\] / 0.072. z score was used for 90% CI. 95 women underwent colposcopic examination and biopsy of at least one quadrant. All patients were positive for at least 1 type of high-risk HPV. Colposcopic features were assessed using the Swede Score and the IFCPC system 2011. The same colposcopist carried out all colposcopies and scoring.

All data collected were statistically analyzed using SPSS statistical software (version 22, Chicago, IL, USA). The Kappa coefficient was calculated to assess inter-rater agreement, while Spearman's rho was used to analyze the relationship between positively paired samples. Concerning the Swede score, the investigators have assessed the effectiveness of using cut-off values of 5 and 7 to identify HSIL. The investigators also examined whether the sensitivity and specificity of these scoring systems changed when they were evaluated together with data on the HPV type and multiple hr-HPV carrier status of the patients.

Descriptive statistics were conducted to analyse the demographic characteristics of the participants. Accuracy, sensitivity, specificity, PPV, NPV, and 95% confidence intervals were calculated by the SPSS program. The AUC construction was calculated from the sensitivity and specificity of the 2011 IFCPC Nomenclature and Swede score. A p-value \< 0.05 was used for all statistical tests to indicate a statistically significant difference.

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Study First Submitted: 2025-04-22
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-31
• Last Update Submitted: 2025-05-31
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

Inclusion Criteria

• Women who are positive for at least 1 type of high-risk HPV.
• Women with high-risk HPV and subjective symptoms such as post-coital bleeding or prolonged leucorrhoea were included in the study.

Exclusion Criteria

• Women with normal colposcopy findings, as defined by both the 2011 IFCPC system and the Swede score
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparison of diagnostic power of the Swede Score and 2011 IFCPC Nomenclature in patients with hr-HPV	6 months	Thestudy aims to compare of diagnostic accuracy of the Swede Score and 2011 IFCPC Nomenclature in patients with hr-HPV. Receiver operating curves (ROC) are used for this comparison.

Secondary Outcome Measures

Name	Time	Method
The effectiveness of the Swede score and IFCPC in hr-HPV carriers according to HPV types and multiple HPV carrier status	6 months	This study aims to evaluate if effectiveness of the Swede score and IFCPC Nomenclature is changed by patients' HPV types and multiple HPV carrier status. For the IFCPC Nomenclature, major findings and for the Swede score, values of 5 and above were evaluated in terms of diagnosing HSIL lesions.
The effectiveness of the Swede score in hr-HPV carriers	6 months	This prospective study aims to examine the effect of Swede score on the prediction of cervical precancerous lesions or cervical cancer in patients referred for colposcopy to the gynecologic oncology clinic of a hospital between June 2024 and November 2024 for high-risk HPV carriers. ROC were used to show the correlation of the scoring system with final pathology results.The values of 5 and above were evaluated in terms of diagnosing HSIL lesions.; Swede Score 0 1 2 Aceto uptake Zero or transparent Milky Opaque white Margins/Surface Diffuse Sharp, geographical satellites Sharp, surface level Vessels Fine and regular Absent Coarse or atypical Lesion size \<5mm 5-15mm or 2 quadrants \>15mm or 3-4 quadrants Iodine staining Brown Yellow Distinct yellow
The effectiveness of the 2011IFCPC Nomenclature in hr-HPV carriers	6 months	This prospective study aims to examine the effect of 2011 IFCPC terminology on the prediction of cervical precancerous lesions or cervical cancer in patients referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital between June 2024 and November 2024 for high-risk HPV carriers. Receiver Operating Curves (ROC) were used tos how the correlation of the scoring system with final pathology results. For the IFCPC Nomenclature, major findings were evaluated in terms of diagnosing HSIL lesions.; Major findings in 2011 IFCPC Nomenclature are defined as; dense acetowhite epithelium, rapid appearance of acetowhitening, cuffed crypt, and coarse mosaic with sharp or inner border.

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Meram, Turkey