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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

Tracking Information
First Submitted Date October 14, 2016
First Posted Date October 18, 2016
Last Update Posted Date April 10, 2019
Study Start Date November 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02937155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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?
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • HSIL, High-Grade Squamous Intraepithelial Lesions
  • Adenocarcinoma in Situ
  • Early Cervical Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Vaccinated
    Patients who have received the HPV vaccine.
  • Vaccine Naive
    Patients who have not received the HPV vaccine.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 14, 2016)
100
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
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, 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sasha Manohar sasha.manohar@sunnybrook.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02937155
Other Study ID Numbers 53257
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor Sunnybrook Health Sciences Centre
Collaborators Merck Canada Inc.
Investigators
Principal Investigator: Allan Covens, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date April 2019