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| Name | Class |
|---|---|
| Merck Canada Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated | Patients who have received the HPV vaccine. | ||
| Vaccine Naive | Patients who have not received the HPV vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline |
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Inclusion 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:
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Women recently diagnosed with either high grade cervical dysplasia, ACIS, on early cervical cancer who present to the Sunnybrook Colposcopy Clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Allan Covens, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 3, 2025 | |
| Reset | Mar 21, 2025 | |
| Release | Apr 14, 2025 |
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| Reset | Apr 30, 2025 |
| Release | May 28, 2025 |
| Reset | Jun 12, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 3, 2025 | Mar 21, 2025 | |||
| Apr 14, 2025 | Apr 30, 2025 | |||
| May 28, 2025 | Jun 12, 2025 |
| ID | Term |
|---|---|
| D000081483 | Squamous Intraepithelial Lesions |
| D065311 | Adenocarcinoma in Situ |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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