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?

NCT02937155 | Unknown

• 1 other identifier: 53257
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HSIL, High-Grade Squamous Intraepithelial Lesions; Adenocarcinoma in Situ; Early Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Vaccinated

Patients who have received the HPV vaccine.

Vaccine Naive

Patients who have not received the HPV vaccine.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Merck Canada Inc.: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Adenocarcinoma in Situ; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Allan Covens, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-04

Locations

CA (1)