Trial Information
Cytology Versus at Home HPV Screening for Detection of CIN 2,3, CIS
Inclusion Criteria:
- Female sex
- >=21 years old
- Able to provide informed consent in English
Exclusion Criteria:
- Male sex
- Have had hysterectomy
- Currently pregnant
- Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or
cryotherapy within two years
- Immunocompromised (positive HIV test, transplant recipient, received chemotherapy for
cancer, or taking immunosuppressant drugs)
- Decisionally impaired adults requiring a legally authorized representative
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Sensitivity and specificity of self-collected at home human papillomavirus test with reflex cytology
Outcome Description:
Compare whether cervical cancer screening of self-collected at home human papillomavirus test with reflex cytology is as effective as the currently recommended approach of cytology with reflex human papillomavirus testing.
Outcome Time Frame:
5 Years
Safety Issue:
No
Principal Investigator
Nancy B Kiviat, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Washington
Authority:
United States: Institutional Review Board
Study ID:
7489
NCT ID:
NCT01550783
Start Date:
March 2012
Completion Date:
August 2016
Related Keywords:
- Cervical Cancer
- Precancerous Condition
- cervical cancer
- atypical squamous cells of undetermined significance
- stage 0 cervical cancer
- cervical intraepithelial neoplasia grade 1
- cervical intraepithelial neoplasia grade 2
- cervical intraepithelial neoplasia grade 3
- Human papillomavirus
- HPV
- Uterine Cervical Neoplasms
- Precancerous Conditions
- Cervical Intraepithelial Neoplasia
Name | Location |
University of Minnesota |
Minneapolis, Minnesota 55455 |
University of Washington |
Seattle, Washington 98195 |