Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727228
Status:
RECRUITING
Last Update Posted:
2023-02-14
First Post:
2023-01-16
Brief Title:
Screening Triage and Risk Stratification
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision
Status:
RECRUITING
Status Verified Date:
2023-02
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:
I-share
Brief Summary:
To investigate the performance of cytology extended genotyping p16Ki67 dual stain cytology DNA methylation and viral load as triage markers in post-menopausal HPV-screen-positive women aged 50-64 years in the organized screening program to predict the risk of developing CIN2 work package 1
To investigate the performance of cytology extended genotyping p16Ki67 dual stain cytology DNA methylation and viral load six months after cervical excision to predict the long-term risk of residualrecurrent CIN2 lesions among women aged 23-64 work-package 2
To investigate the performance of cytology extended genotyping p16Ki67 dual stain cytology DNA methylation and viral load six months after cervical excision to predict the long-term risk of residualrecurrent CIN2 lesions among women aged 23-64 work-package 2
Detailed Description:
As HPV-positive women may have a transient infection which would be cleared with treatment triage of HPV-positive women are needed to decrease the colposcopy referral Liquid-based cytology hereinafter cytology are often used as triage for HPV-positive women HPV 1618 are the predominant HPV types in younger women and are for all aged referred directly for colposcopy However as women age hrHPV other types become more prevalent10 and these types are triaged with cytology However as cytology undergo subjective interpretation and as it may have a decreased sensitivity in with increasing age11 12 cytology may not be the most optimal triage marker in postmenopausal women
p16Ki67 dual stain cytology hereinafter DS is another triage marker p16 is a cell-cycle regulator protein and Ki67 is a proliferation-associated protein which under normal circumstances are mutual exclusive Thus in an HPV-transformed cell co-expression of p16 and Ki67 indicates cell deregulation and increased risk of cervical precancer13 In several studies DS have shown better sensitivity and negative predictive value NPV as compared to cytology in triaging HPV-positive women14-17 and women with low-grade cytology ASC-US and LSIL18-20
Methylation of HPV-positive women benefits from a more objective evaluation than both cytology and DS and has in shown promising results in triaging HPV-positive women21 Most studies on DS and methylation have however been conducted in younger women and studies evaluation the performance in postmenopausal women are needed
Women diagnosed with CIN2 undergo excisional treatment removing the lesions and thereby reducing the womans risk of developing cervical cancer The most frequently used method is loop electrosurgical excision procedure LEEP Despite treatment women previously diagnosed with CIN3 lesion are at greater risk of developing cervical cancer with the risk increasing with increasing age22 Surveillance after LEEP consist of test-of cure ie cytology and HPV test six months after LEEP in several countries23-27 Treatment of CIN2 is however not always successful and residual or recurrent high-grade disease CIN2 occurs on average in 8 ranging from 4 to 18 of treated women with the majority of treatment failure occurring mainly the first two post-operative years28 29 Persistent HPV infection and positive margins after LEEP are risk factors for residual or recurrent disease after LEEP28 However not all women are at the same risk of recurrent disease but still managed the same way as women at higher risk and therefore a future risk-stratification are needed to individualize the follow-up pathways Moreover introduction of a risk-stratification in the follow-up pathway may also decrease the number of open-ended follow-up pathways In a recent study in HPV-positive women 60-64 years only 26 had follow-up as recommended30
p16Ki67 dual stain cytology hereinafter DS is another triage marker p16 is a cell-cycle regulator protein and Ki67 is a proliferation-associated protein which under normal circumstances are mutual exclusive Thus in an HPV-transformed cell co-expression of p16 and Ki67 indicates cell deregulation and increased risk of cervical precancer13 In several studies DS have shown better sensitivity and negative predictive value NPV as compared to cytology in triaging HPV-positive women14-17 and women with low-grade cytology ASC-US and LSIL18-20
Methylation of HPV-positive women benefits from a more objective evaluation than both cytology and DS and has in shown promising results in triaging HPV-positive women21 Most studies on DS and methylation have however been conducted in younger women and studies evaluation the performance in postmenopausal women are needed
Women diagnosed with CIN2 undergo excisional treatment removing the lesions and thereby reducing the womans risk of developing cervical cancer The most frequently used method is loop electrosurgical excision procedure LEEP Despite treatment women previously diagnosed with CIN3 lesion are at greater risk of developing cervical cancer with the risk increasing with increasing age22 Surveillance after LEEP consist of test-of cure ie cytology and HPV test six months after LEEP in several countries23-27 Treatment of CIN2 is however not always successful and residual or recurrent high-grade disease CIN2 occurs on average in 8 ranging from 4 to 18 of treated women with the majority of treatment failure occurring mainly the first two post-operative years28 29 Persistent HPV infection and positive margins after LEEP are risk factors for residual or recurrent disease after LEEP28 However not all women are at the same risk of recurrent disease but still managed the same way as women at higher risk and therefore a future risk-stratification are needed to individualize the follow-up pathways Moreover introduction of a risk-stratification in the follow-up pathway may also decrease the number of open-ended follow-up pathways In a recent study in HPV-positive women 60-64 years only 26 had follow-up as recommended30
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