Clinical trial · Observational
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?
HSIL/ACIS/Early Cervical Cancer: What Are The Current Causative HPV Subtypes in the Era of HPV Vaccination?
NCT02937155CI-TRIAL-00071626unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma in Situ | Adenocarcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Early Cervical Cancer | — | UNRESOLVED | — |
| HSIL, High-Grade Squamous Intraepithelial Lesions | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Vaccinated
- description
- Patients who have received the HPV vaccine.
- label
- Vaccine Naive
- description
- Patients who have not received the HPV vaccine.
Primary outcomes (2)
- measure
- Overall prevalence of HPV subtypes
- timeFrame
- Baseline
- description
- 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.
- measure
- Reasons for vaccine failures
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.