Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870787
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-05-12
Brief Title:
IMproving the DIagnostics and Treatment of CeRvical Precancer
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
IMproving the DIagnostics and Treatment of CeRvical Precancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDIATOR
Brief Summary:
Cervical cancer screening is important as it enables identification of women at increased risk of the disease but high-quality diagnostics of screen-positive women and effective treatment of those with precancer are critical in preventing progression to cancer With the current transition from cytology-based to primary human papillomavirus HPV-screening and a growing proportion of HPV-vaccinated women diagnostics of screen-positive women will become more challenging in the decades to come Thus there is a need to explore how to improve diagnostics while ensuring a low number of unnecessary procedures such as colposcopy and the collection of multiple cervical biopsies
The overall purpose is
To investigate the diagnostic accuracy of cervical precancer when using a colposcopic scoring system in the diagnostic work-up of screen-positive women
To investigate the performance of a colposcopic scoring system to identify women without cervical precancer in whom collection of biopsies can be safely omitted
The overall purpose is
To investigate the diagnostic accuracy of cervical precancer when using a colposcopic scoring system in the diagnostic work-up of screen-positive women
To investigate the performance of a colposcopic scoring system to identify women without cervical precancer in whom collection of biopsies can be safely omitted
Detailed Description:
Introduction Cervical cancer is the fourth most common cancer in women worldwide Every year 375 women are diagnosed with cervical cancer in Denmark and approximately 90 women die from the disease Cervical cancer is caused by the sexually transmitted virus human papillomavirus HPV When infected about 85-90 clear the virus within a year or two The remaining women develop a persistent HPV infection which is associated with an increased risk of cervical intraepithelial neoplasia CIN which may progress to cancer if left untreated Cervical cancer can be prevented through prophylactic HPV vaccination and screening In Denmark women aged 23 - 64 years are invited to the screening program Women who do not participate in regular screening have an increased risk of cervical cancer however up to 55 of cervical cancers are diagnosed in women who have attended screening Hence the performance of diagnostics is crucial
Diagnostics Women with abnormal screening results may undergo repeat testing or be referred for colposcopy Colposcopy allows the colposcopist to magnify and visualize the cervix with the transformation zone where cervical cancer and cervical lesions typically arise The aim is to make a colposcopic diagnosis and select the most severe area for biopsies which undergo histopathological examination Studies have shown considerable inter- and intra-observer variability even among experienced colposcopists and a variable sensitivity of colposcopy as low as 55-57 These findings suggest a need to improve the detection rate of CIN2 A validated colposcopic scoring system the Swede score has been designed to improve the detection of high-grade cervical lesions specified as cervical intraepithelial neoplasia grade 2 or worse CIN2 by providing an systematic approach to the colposcopy examination The Swede score includes five variables degree of 1 acetowhitening 2 margins and surface 3 vessels 4 lesion size and 5 iodine staining by using Lugols iodine with a score from 0 - 2 Conventional colposcopy only utilizes acetic acid In the original study the Swede score had a high sensitivity and specificity for detecting high-grade cervical lesions CIN2 with an area under the receiver operating characteristics ROC curve of 087 Even so the Swede score is endorsed by the International Agency for Research on Cancer IARCWHO and by the European Federation for Colposcopy EFC it has not yet been implemented in Denmark As previous studies have mostly evaluated the use of the Swede score among expert colposcopists it is important to assess whether the score may be a valuable tool among non-experts In Denmark colposcopy is mostly performed by non-experts gynecologists As a result of the low performance of colposcopy and because several studies have shown that the CIN2 detection rate increases with the number of biopsies collected the Danish national guidelines recommend that all women should have a minimum of 4 biopsies collected Biopsies should be collected from abnormal areas of the cervix and if no lesion is detected random biopsies should be taken Our neighboring Scandinavian countries for example Sweden and Finland do not recommend collection of random biopsies If biopsies could be omitted without increasing the risk of missing disease and reducing the harms with pain bleeding and discomfort this would benefit the women
Aim The project aims to explore whether the implementation of a systematic colposcopic scoring system the Swede score can improve diagnostic accuracy of cervical lesions with detection of CIN2 in a Danish clinical setting Furthermore we want to evaluate whether the Swede score can be used to assess when random biopsies can be safely omitted
Data Characteristics of the women will be collected from medical records previous gynecological historic parity smoking status HPV-vaccination status hormone use or immunosuppressive treatment From the Danish Pathology Databank we will collect data on previous screening history result of the referral screening test result of current and subsequent cervical biopsies andor cervical excision
Diagnostics Women with abnormal screening results may undergo repeat testing or be referred for colposcopy Colposcopy allows the colposcopist to magnify and visualize the cervix with the transformation zone where cervical cancer and cervical lesions typically arise The aim is to make a colposcopic diagnosis and select the most severe area for biopsies which undergo histopathological examination Studies have shown considerable inter- and intra-observer variability even among experienced colposcopists and a variable sensitivity of colposcopy as low as 55-57 These findings suggest a need to improve the detection rate of CIN2 A validated colposcopic scoring system the Swede score has been designed to improve the detection of high-grade cervical lesions specified as cervical intraepithelial neoplasia grade 2 or worse CIN2 by providing an systematic approach to the colposcopy examination The Swede score includes five variables degree of 1 acetowhitening 2 margins and surface 3 vessels 4 lesion size and 5 iodine staining by using Lugols iodine with a score from 0 - 2 Conventional colposcopy only utilizes acetic acid In the original study the Swede score had a high sensitivity and specificity for detecting high-grade cervical lesions CIN2 with an area under the receiver operating characteristics ROC curve of 087 Even so the Swede score is endorsed by the International Agency for Research on Cancer IARCWHO and by the European Federation for Colposcopy EFC it has not yet been implemented in Denmark As previous studies have mostly evaluated the use of the Swede score among expert colposcopists it is important to assess whether the score may be a valuable tool among non-experts In Denmark colposcopy is mostly performed by non-experts gynecologists As a result of the low performance of colposcopy and because several studies have shown that the CIN2 detection rate increases with the number of biopsies collected the Danish national guidelines recommend that all women should have a minimum of 4 biopsies collected Biopsies should be collected from abnormal areas of the cervix and if no lesion is detected random biopsies should be taken Our neighboring Scandinavian countries for example Sweden and Finland do not recommend collection of random biopsies If biopsies could be omitted without increasing the risk of missing disease and reducing the harms with pain bleeding and discomfort this would benefit the women
Aim The project aims to explore whether the implementation of a systematic colposcopic scoring system the Swede score can improve diagnostic accuracy of cervical lesions with detection of CIN2 in a Danish clinical setting Furthermore we want to evaluate whether the Swede score can be used to assess when random biopsies can be safely omitted
Data Characteristics of the women will be collected from medical records previous gynecological historic parity smoking status HPV-vaccination status hormone use or immunosuppressive treatment From the Danish Pathology Databank we will collect data on previous screening history result of the referral screening test result of current and subsequent cervical biopsies andor cervical excision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None