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

NCT07012356 | Completed

• 1 other identifier: 2024/4991
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Colposcopy; HPV; HSIL

Keywords

colposcopy; HPV; HSIL

Outcome Measures

Primary Outcomes (1)

• The comparison of diagnostic power of the Swede Score and 2011 IFCPC Nomenclature in patients with hr-HPV

  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.

  6 months

Secondary Outcomes (3)

• The effectiveness of the Swede score and IFCPC in hr-HPV carriers according to HPV types and multiple HPV carrier status

  6 months

• The effectiveness of the Swede score in hr-HPV carriers

  6 months

• The effectiveness of the 2011IFCPC Nomenclature in hr-HPV carriers

  6 months

Study Arms (1)

hr-HPV positive women who undergo colposcopy

Women referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital between June 2024 and November 2024 for high-risk HPV carriers.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This is a study about effectiveness of colposcopy, so female participants who have cervix uteri can be involved in the study. Women without a cervix (due to a n operation or congenital) are excluded.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (13)

• Alan M, Gunyeli I, Gultekin M, Sanci M, Yuce K. Correlation of Swede score colposcopy scoring system and histopathological results in patients with high-risk HPV infection other than HPV16 and 18. Int J Gynecol Cancer. 2020 Jan;30(1):35-40. doi: 10.1136/ijgc-2019-000932. Epub 2019 Dec 1.

  PMID: 31792083 RESULT

• Rahman Z, Yadav G, Tripathi U. The Diagnostic Efficacy of Swede Score for Prediction of Pre-invasive Cervical Lesions: A Prospective Hospital-Based Study. J Obstet Gynaecol India. 2020 Dec;70(6):497-502. doi: 10.1007/s13224-020-01344-2. Epub 2020 Jul 4.

  PMID: 33417628 RESULT

• Li Y, Duan X, Sui L, Xu F, Xu S, Zhang H, Xu C. Closer to a Uniform Language in Colposcopy: Study on the Potential Application of 2011 International Federation for Cervical Pathology and Colposcopy Terminology in Clinical Practice. Biomed Res Int. 2017;2017:8984516. doi: 10.1155/2017/8984516. Epub 2017 May 25.

  PMID: 28626767 RESULT

• Fan A, Wang C, Zhang L, Yan Y, Han C, Xue F. Diagnostic value of the 2011 International Federation for Cervical Pathology and Colposcopy Terminology in predicting cervical lesions. Oncotarget. 2018 Jan 8;9(10):9166-9176. doi: 10.18632/oncotarget.24074. eCollection 2018 Feb 6.

  PMID: 29507681 RESULT

• Li J, Wang W, Yang P, Chen J, Dai Q, Hua P, Liu D. Analysis of the agreement between colposcopic impression and histopathological diagnosis of cervical biopsy in a single tertiary center of Chengdu. Arch Gynecol Obstet. 2021 Oct;304(4):1033-1041. doi: 10.1007/s00404-021-06012-y. Epub 2021 Mar 8.

  PMID: 33683424 RESULT

• Qin D, Bai A, Xue P, Seery S, Wang J, Mendez MJG, Li Q, Jiang Y, Qiao Y. Colposcopic accuracy in diagnosing squamous intraepithelial lesions: a systematic review and meta-analysis of the International Federation of Cervical Pathology and Colposcopy 2011 terminology. BMC Cancer. 2023 Feb 23;23(1):187. doi: 10.1186/s12885-023-10648-1.

  PMID: 36823557 RESULT

• Zhang B, Hong S, Zhang G, Rong F. Clinical application of the 2011 IFCPC colposcope terminology. BMC Womens Health. 2021 Jun 24;21(1):257. doi: 10.1186/s12905-021-01395-1.

  PMID: 34167543 RESULT

• Bowring J, Strander B, Young M, Evans H, Walker P. The Swede score: evaluation of a scoring system designed to improve the predictive value of colposcopy. J Low Genit Tract Dis. 2010 Oct;14(4):301-5. doi: 10.1097/LGT.0b013e3181d77756.

  PMID: 20885156 RESULT

• Quaas J, Reich O, Frey Tirri B, Kuppers V. Explanation and Use of the Colposcopy Terminology of the IFCPC (International Federation for Cervical Pathology and Colposcopy) Rio 2011. Geburtshilfe Frauenheilkd. 2013 Sep;73(9):904-907. doi: 10.1055/s-0033-1350824.

  PMID: 24771940 RESULT

• Bornstein J, Bentley J, Bosze P, Girardi F, Haefner H, Menton M, Perrotta M, Prendiville W, Russell P, Sideri M, Strander B, Tatti S, Torne A, Walker P. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol. 2012 Jul;120(1):166-72. doi: 10.1097/AOG.0b013e318254f90c.

  PMID: 22914406 RESULT

• Wang P, Gao D, Yu X, Zhu G. Value of high-risk human papillomavirus detection combined with colposcopy in the diagnosis of cervical cancer and precancerous lesions. Oncol Lett. 2024 Feb 29;27(4):185. doi: 10.3892/ol.2024.14318. eCollection 2024 Apr.

  PMID: 38476208 RESULT

• Campos PL, Guimaraes ICCDV, Fialho SCAV, Martins CAO, Rodrigues FR, Velarde LGC, Monteiro DDSA. Association of Swede Score and 2011 IFCPC Nomenclature in Women with Abnormal Cytology. Rev Bras Ginecol Obstet. 2022 Oct;44(10):938-944. doi: 10.1055/s-0042-1751074. Epub 2022 Nov 29.

  PMID: 36446560 RESULT

• Li M, Du X, Lu M, Zhang W, Sun Z, Li L, Ye M, Fan W, Jiang S, Liu A, Wang M, Meng Y, Li Y. Prevalence characteristics of single and multiple HPV infections in women with cervical cancer and precancerous lesions in Beijing, China. J Med Virol. 2019 Mar;91(3):473-481. doi: 10.1002/jmv.25331. Epub 2018 Nov 13.

  PMID: 30281807 RESULT

Study Officials

• Cemre Alan, Dr

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)