Clinical trial NCT07012356: Does Hr-HPV Status Influence the 2011 IFCPC Nomenclature and Swede Score's Capacity to Diagnose Precancerous Lesions?
Official title: Does The Type of Hr-HPV and Multiple HPV Carrier Status Increase The Effectiveness of The Colposcopy in Diagnosing Preinvasive Lesions Using The Swede Score and The 2011 IFCPC Nomenclature?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colposcopy
HPV
HSIL
Keywords: colposcopy
HPV
HSIL
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: The comparison of diagnostic power of the Swede Score and 2011 IFCPC Nomenclature in patients with hr-HPV
timeFrame: 6 months
Secondary outcomes:
measure: The effectiveness of the Swede score and IFCPC in hr-HPV carriers according to HPV types and multiple HPV carrier status
timeFrame: 6 months
measure: The effectiveness of the Swede score in hr-HPV carriers
timeFrame: 6 months
measure: The effectiveness of the 2011IFCPC Nomenclature in hr-HPV carriers
timeFrame: 6 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
affiliation: Necmettin Erbakan University
name: Cemre Alan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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