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Cytology Versus at Home HPV Screening for Detection of CIN 2,3, CIS


N/A
21 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Precancerous Condition

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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 MinnesotaMinneapolis, Minnesota  55455
University of WashingtonSeattle, Washington  98195