An observational study in HSIL, High-Grade Squamous Intraepithelial Lesions, Adenocarcinoma in Situ and Early Cervical Cancer, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Sunnybrook Health Sciences Centre · Observational
This study will look at cervical tissue samples in women with abnormal cervical cells to see if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV vaccine with those who have not.
The development of cervical dysplasia (precursor to cervical cancer) and cervical cancer requires infection with one of several cancer causing subtypes of the human papilloma virus (HPV). There are over 100 subtypes of HPV, and most are not cancer causing. In the past, North American data has shown that 70% of early cervical cancers were associated with HPV subtypes 16 and/or 18. The first HPV vaccines to be approved protected against the common subtypes of HPV 16 and 18. The traditional HPV vaccination consists of 3-doses administered over a 6 month period.
Since the 8 years after the introduction of the vaccine, there have not been any studies analyzing HPV subtype changes. It is important to determine if the prevalence of the HPV subtypes associated with precancerous and/or early cervical cancer have changed, and what preventative outcomes have arisen from the HPV vaccination. This will have implications regarding the importance and anticipated effects of immunization with the nanovalent vaccine that includes other oncogenic subtypes.
This study will look at tissue samples to see if the frequency of the HPV 16/18 subtypes has changed in female populations today, after the introduction of the HPV vaccine. It will compare women who have been exposed to the HPV vaccine with those who have not.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 100 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women recently diagnosed with either high grade cervical dysplasia, ACIS, on early cervical cancer who present to the Sunnybrook Colposcopy Clinic.
Expected to have a cervical biopsy, loop electrosurgical excision procedure (LEEP), or cone biopsy as part of standard of care treatment OR Has already had a cone biopsy of LEEP and the archived tissue is located at Sunnybrook Health Sciences Centre and was taken within two years from the time of consent.
Exclusion Criteria:
Patients who have received the HPV vaccine.
Patients who have not received the HPV vaccine.
Overall prevalence of HPV subtypes
To determine the prevalence of HPV subtypes in HSIL/ACIS/early cervical cancer in patients who have been exposed or naïve to an HPV vaccine.
Time frame: Baseline
Reasons for vaccine failures
A descriptive analysis to explore the potential reasons for HPV vaccine failures in women with HSIL/ACIS/early cervical cancer in patients who have been exposed to an HPV vaccine.
Time frame: Baseline
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre