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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?

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ClinicalTrials.gov Identifier: NCT02937155
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Merck Canada Inc.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease
HSIL, High-Grade Squamous Intraepithelial Lesions Adenocarcinoma in Situ Early Cervical Cancer

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HSIL/ACIS/Early Cervical Cancer: What Are The Current Causative HPV Subtypes in the Era of HPV Vaccination?
Study Start Date : November 2016
Estimated Primary Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort
Vaccinated
Patients who have received the HPV vaccine.
Vaccine Naive
Patients who have not received the HPV vaccine.



Primary Outcome Measures :
  1. Overall prevalence of HPV subtypes [ Time Frame: Baseline ]
    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.

  2. Reasons for vaccine failures [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937155


Contacts
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Contact: Sasha Manohar sasha.manohar@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Merck Canada Inc.
Investigators
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Principal Investigator: Allan Covens, MD Sunnybrook Health Sciences Centre

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02937155     History of Changes
Other Study ID Numbers: 53257
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Adenocarcinoma
Uterine Cervical Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Adenocarcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Dysplasia
Precancerous Conditions
Carcinoma in Situ
Vaccines
Immunologic Factors
Physiological Effects of Drugs