ColposcopyNCT07012356
Does Hr-HPV Status Influence the 2011 IFCPC Nomenclature and Swede Score's Capacity to Diagnose Precancerous Lesions?
An observational study of Colposcopy and HPV, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Colposcopy, HPV, HSIL
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital
Who may be able to join
- 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.
Who cannot join
- Women with normal colposcopy findings, as defined by both the 2011 IFCPC system and the Swede score
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
About this study
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?
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.
Read the 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.
- Conditions
- Colposcopy, HPV, HSIL
- Keywords
- colposcopy, HPV, HSIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 months
The effectiveness of the Swede score in hr-HPV carriers
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
Measured: 6 months
The effectiveness of the 2011IFCPC Nomenclature in hr-HPV carriers
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ColposcopyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Alan, Necmettin Erbakan University
- Investigators
- Cemre Alan, Dr, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012356
- Sponsor's protocol ID
- 2024/4991
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31792083Rahman 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.
PubMed 33417628Li 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.
PubMed 28626767Fan 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.
PubMed 29507681Li 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.
PubMed 33683424Qin 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.
PubMed 36823557Zhang 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.
PubMed 34167543Bowring 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.
PubMed 20885156Quaas 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.
PubMed 24771940Bornstein 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.
PubMed 22914406Wang 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.
PubMed 38476208Campos 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.
PubMed 36446560Li 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.
PubMed 30281807
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT07012356
- Acronym / sponsor ID
- 2024/4991
- Conditions
- Colposcopy, HPV, HSIL
- Keywords
- colposcopy, HPV, HSIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred for colposcopy to the gynecologic oncology outpatient clinic of a university hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Women with normal colposcopy findings, as defined by both the 2011 IFCPC system and the Swede score
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The comparison of diagnostic power of the Swede Score and 2011 IFCPC Nomenclature in patients with hr-HPV
Time frame: 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.
3 secondary outcomes
The effectiveness of the Swede score and IFCPC in hr-HPV carriers according to HPV types and multiple HPV carrier status
Time frame: 6 months
The effectiveness of the Swede score in hr-HPV carriers
Time frame: 6 months
The effectiveness of the 2011IFCPC Nomenclature in hr-HPV carriers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Results publication: PubMed 31792083Alan 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.
- Results publication: PubMed 33417628Rahman 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.
- Results publication: PubMed 28626767Li 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.
- Results publication: PubMed 29507681Fan 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.
- Results publication: PubMed 33683424Li 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.
- Results publication: PubMed 36823557Qin 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.
- Results publication: PubMed 34167543Zhang 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.
- Results publication: PubMed 20885156Bowring 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.
- Results publication: PubMed 24771940Quaas 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.
- Results publication: PubMed 22914406Bornstein 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.
- Results publication: PubMed 38476208Wang 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.
- Results publication: PubMed 36446560Campos 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.
- Individual participant dataSharing planned: No
Related trials for Colposcopy
Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
RecruitingObservational study
Vaginal Wall Retraction Using VuSleeve
Adult Females
Not yet recruiting
Embodied Conversational Agents for CervicalCancer Screening Abnormalities
Cervical Cancer Screening
Recruiting
Improving Diagnostics in Cervical Dysplasia
Cervical Cancer
Not yet recruitingObservational study
VIA Versus Colposcopy
Cervical Intraepithelial Neoplasia (CIN), Cervicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemre Alan, Dr principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colposcopy and HPV, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of diagnostic power of the Swede Score and 2011 IFCPC Nomenclature in patients with hr-HPV (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012356, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.