Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327568
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-18
Brief Title:
Anal Cancer andor Precancer Screening Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Anal Cancer andor Precancer Screening Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Human papillomavirus HPV infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95 of anal tumors Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors AIN H-SIL to invasive anal tumors
The diagnosis of AIN is made by cytology or biopsy during routine examinations To date no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose
The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach
The diagnosis of AIN is made by cytology or biopsy during routine examinations To date no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose
The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach
Detailed Description:
Anal cancer is a rare disease in the general population but its incidence is higher in certain at-risk groups such as immunosuppressed individuals including those with HIV infections and post-organ transplantation patients men who have sex with men and women with HPV-related lower genital tract dysplasia or cancer
A squamous intraepithelial anal lesion is the dysplastic growth of squamous epithelial cells in the transition zone of the anal canal This lesion is pre-malignant and can progress to anal squamous cell carcinoma if left untreated
Human papillomavirus HPV infection has been implicated as the necessary cause for the development of the majority of anogenital malignancies accounting for approximately 95 of anal cancers Persistent infection with HR-HPV promotes progression from high-grade squamous intraepithelial lesions H-SIL to invasive anal cancers In the anal canal low-grade intraepithelial lesion LSIL correlates with anal intraepithelial neoplasia AIN-1 or anal condyloma while high grade squamous intraepithelial lesion HSIL correlates with AIN-2 and AIN-3
Prevalence of H-SIL is around 40 to 50 Progression from H-SIL to anal cancer is about 1250 per year in HIV-positive MSM and 15000 per year in HIV-negative MSM respectively
The diagnosis of AIN is made from cytology or biopsy during routine examinations
Up to date different guidelines for anal cancer screening have been proposed but are not uniform These include 1 digital ano-rectal examination useful in unrecognized but symptomatic subjects and 2 anal cytology useful in asymptomatic subjects only if high-resolution anoscopy is available
These observations support the need to implement screening to prevent anal precancers and cancers
At this moment no HPV assay has been validated for anal specimens and none is available in the molecular diagnostics market
Validation of HPV typing methods on anal specimens could implement anal cancer screening without an invasive procedure and with an easy approach for the patient
The BD Onclarity HPV Assay BD Diagnostics Sparks USA is a real-time polymerase chain reaction PCR assay that detects type-specific genomic DNA The target of the assay is the E6 and E7 HPV genes It simultaneously detects all 14 high-risk HPV types and can provide an extended genotype information on six individual genotypes HPV 16 18 31 45 51 and 52 and in three distinct groups 33 and 58 56 59 and 66 and 3539 and 68 Briefly the DNA was extracted using BD FOX magnetic particles and the eluate-containing DNA was used to set up three PCR genotyping reactions G1 detects HPV 16 HPV 18 and HPV 45 plus the internal beta globin control G2 detects HPV 31 HPV 33_58 and HPV 56_59_66 plus the internal beta globin
A squamous intraepithelial anal lesion is the dysplastic growth of squamous epithelial cells in the transition zone of the anal canal This lesion is pre-malignant and can progress to anal squamous cell carcinoma if left untreated
Human papillomavirus HPV infection has been implicated as the necessary cause for the development of the majority of anogenital malignancies accounting for approximately 95 of anal cancers Persistent infection with HR-HPV promotes progression from high-grade squamous intraepithelial lesions H-SIL to invasive anal cancers In the anal canal low-grade intraepithelial lesion LSIL correlates with anal intraepithelial neoplasia AIN-1 or anal condyloma while high grade squamous intraepithelial lesion HSIL correlates with AIN-2 and AIN-3
Prevalence of H-SIL is around 40 to 50 Progression from H-SIL to anal cancer is about 1250 per year in HIV-positive MSM and 15000 per year in HIV-negative MSM respectively
The diagnosis of AIN is made from cytology or biopsy during routine examinations
Up to date different guidelines for anal cancer screening have been proposed but are not uniform These include 1 digital ano-rectal examination useful in unrecognized but symptomatic subjects and 2 anal cytology useful in asymptomatic subjects only if high-resolution anoscopy is available
These observations support the need to implement screening to prevent anal precancers and cancers
At this moment no HPV assay has been validated for anal specimens and none is available in the molecular diagnostics market
Validation of HPV typing methods on anal specimens could implement anal cancer screening without an invasive procedure and with an easy approach for the patient
The BD Onclarity HPV Assay BD Diagnostics Sparks USA is a real-time polymerase chain reaction PCR assay that detects type-specific genomic DNA The target of the assay is the E6 and E7 HPV genes It simultaneously detects all 14 high-risk HPV types and can provide an extended genotype information on six individual genotypes HPV 16 18 31 45 51 and 52 and in three distinct groups 33 and 58 56 59 and 66 and 3539 and 68 Briefly the DNA was extracted using BD FOX magnetic particles and the eluate-containing DNA was used to set up three PCR genotyping reactions G1 detects HPV 16 HPV 18 and HPV 45 plus the internal beta globin control G2 detects HPV 31 HPV 33_58 and HPV 56_59_66 plus the internal beta globin
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