Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06327568 |
| Other study ID # |
IEO 1663 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 17, 2022 |
| Est. completion date |
June 17, 2029 |
Study information
| Verified date |
March 2024 |
| Source |
European Institute of Oncology |
| Contact |
Fabio Bottari |
| Phone |
+390294372716 |
| Email |
fabio.bottari[@]ieo.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 1/250
per year in HIV-positive MSM and 1/5000 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 35,39 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.
