Clinical trial NCT02937155: In the Era of the HPV Vaccine, What Are The Current HPV Subtypes Contributing to High Grade Cervical Dysplasia, Adenocarcinoma in Situ, and Early Cervical Cancer?
Official title: HSIL/ACIS/Early Cervical Cancer: What Are The Current Causative HPV Subtypes in the Era of HPV Vaccination?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HSIL, High-Grade Squamous Intraepithelial Lesions
Adenocarcinoma in Situ
Early Cervical Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Merck Canada Inc.
First posted: 2016-10-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women recently diagnosed with either high grade cervical dysplasia, ACIS, on early cervical cancer who present to the Sunnybrook Colposcopy Clinic.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years old
* Presenting with cervical high grade intraepithelial dysplasia (HSIL), adenocarcinoma in situ (ACIS), or early cervical cancer
* Fulfills one of the following two criteria:

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:

* A history of HSIL, ACIS, or early cervical cancer prior to 2010
* Patients who are unable to provide consent
* Women who have had a previous LEEP or cone biopsy and tissue removed is greater than 2 years old, from the time of consent
* women who have had a previous LEEP or cone biopsy and tissue is archived at an outside institution

Primary outcomes:
measure: Overall prevalence of HPV subtypes
timeFrame: Baseline
measure: Reasons for vaccine failures
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Allan Covens, MD
role: PRINCIPAL_INVESTIGATOR
References: