Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04687267
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-12-10
Brief Title:
Conservative Management of CIN2 Lesions and Biomarkers Evaluation
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
Gestione Conservativa di Lesioni CIN2 e Valutazione di Biomarcatori Indicativi di Regressione
Status:
COMPLETED
Status Verified Date:
2023-09
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:
None
Brief Summary:
Prospective study including women aged 25-45 years adherent to the cervical screening program of four different centers of the Veneto region with a diagnosis of CIN2 lesion After enrollment according to predefined criteria and informed consent to participate the CIN2 lesions are managed by follow-up cases with progressive lesions will be treated immediately cases with CIN2 persistence for more than 12 months will be treated as well Viral molecular and immunocytochemical biomarkers will be studied and evaluated in relation to the clinical outcome
Detailed Description:
Women aged 25-45 years adherent to the organized population-based cervical screening program with a histological diagnosis of CIN2 and fulfilling the inclusion criteria will be invited to participate to the study previously providing specific information in case of acceptance informed consent is signed
STUDY PROTOCOL
The adherent women will attend periodical control visits
every 6 months up to 24 months with performance of pap test PT and colposcopy with biopsy in case of visible alterations
at 6 and 12 months control visit a liquid-based sample of cervical cells will be collected for the biomarkers analyses
BIOMARKERS
1 - HPV search and partial HPV1618 genotyping by cobas 4800 high-risk HPV assay Roche PCR with MY09MY11 consensus primers and full genotyping by restriction fragment length analysis plus PCR with beta-globin primers in-house
2 - methylation analysis of the cellular genes FAM194A and hsa-mir124-2 by methylation-specific quantitative PCR test qMSP - QIAsure methylation test Qiagen
3 - methylation analysis of the L1 and L2 viral genes of HPV types 16 and 18 by pyrosequencing
4 - immunocytochemical analysis for p16INK4AKi67 proteins dual stain by p16INK4AKi67 immunocytochemical analysis by CINtec Plus kit Roche
STUDY PROTOCOL
The adherent women will attend periodical control visits
every 6 months up to 24 months with performance of pap test PT and colposcopy with biopsy in case of visible alterations
at 6 and 12 months control visit a liquid-based sample of cervical cells will be collected for the biomarkers analyses
BIOMARKERS
1 - HPV search and partial HPV1618 genotyping by cobas 4800 high-risk HPV assay Roche PCR with MY09MY11 consensus primers and full genotyping by restriction fragment length analysis plus PCR with beta-globin primers in-house
2 - methylation analysis of the cellular genes FAM194A and hsa-mir124-2 by methylation-specific quantitative PCR test qMSP - QIAsure methylation test Qiagen
3 - methylation analysis of the L1 and L2 viral genes of HPV types 16 and 18 by pyrosequencing
4 - immunocytochemical analysis for p16INK4AKi67 proteins dual stain by p16INK4AKi67 immunocytochemical analysis by CINtec Plus kit Roche
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