Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs

NCT01316120 | Unknown

• 1 other identifier: HPVDry
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis.

Conditions

Human Papillomavirus Infection

Keywords

Self-collected vaginal samples; HPV; HPV self-obtained sample; HPV specimen transport medium

Outcome Measures

Primary Outcomes (1)

• To assess sensibility and specificity of dry swabs for HPV diagnosis

  Agreement between collection methods in terms of HPV risk categories will be measured using the kappa statistic ( ) with a precision of 10% (95% confidence interval). This measure of agreement is 0 when the amount of agreement is what would be expected by chance and 1 when there is perfect agreement.

  day 1

Secondary Outcomes (2)

• Preference about HPV self-collection

  day 1

• Sensitivity and specificity of specimen transport medium (STM)

  day 1

Study Arms (2)

HPV Dry first

EXPERIMENTAL

Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests

Other: Compare different self-obtained specimen for HPV identification

HPV standard transport medium

EXPERIMENTAL

Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests

Other: Compare different self-obtained specimen for HPV identification

Interventions

Compare different self-obtained specimen for HPV identification OTHER

Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.

HPV Dry first

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older,
• First consultation in our colposcopy unit,
• Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF).

You may not qualify if:

• Previous hysterectomy,
• Pregnant,
• Virgin,
• Not able to comply with the protocol study.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Related Publications (1)

• Eperon I, Vassilakos P, Navarria I, Menoud PA, Gauthier A, Pache JC, Boulvain M, Untiet S, Petignat P. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing. BMC Cancer. 2013 Jul 22;13:353. doi: 10.1186/1471-2407-13-353.

  PMID: 23875668 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Petignat, Prof

  HUG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: November 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12