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Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?


Phase 3
20 Years
65 Years
Not Enrolling
Female
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia

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Trial Information

Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?


Inclusion Criteria:



- Women between 20 and 65

Exclusion Criteria:

- Menstruation

- pregnant

- Inability to give informed consent

- Vaccinated against HPV 16 and 18

- Total Hysterectomy

- treatment of CIN 1, 2 or 3

- Abnormal smear in the past year

- Smear in the past 2 years

- Virgin

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Concordance between the three HPV tests

Outcome Time Frame:

End of the study

Safety Issue:

No

Principal Investigator

Ken HAGUENOER

Investigator Role:

Study Director

Investigator Affiliation:

Fran├žois Rabelais University, Public Health Laboratory, Tours, France

Authority:

France: Ministry of Health

Study ID:

INCA08-KH/APACHE-1

NCT ID:

NCT01014026

Start Date:

September 2009

Completion Date:

March 2011

Related Keywords:

  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Mass Screening
  • Polymerase Chain Reaction
  • Vaginal Smears
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia

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