Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting (PETAHG)

Tampon Innovations

Status: Not yet enrolling

Conditions: CIN2

Treatments: Device: Daye Diagnostic Tampon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06210074

PETAHG-ED-001

Details and patient eligibility

About

Evaluation of the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of Human Papilloma Virus (HPV) infection associated with high grade cervical disease. Cross sectional design with comparison to a clinician taken biospecimen. Performance will be measured relative to the presence/absence of histologically confirmed disease

Full description

Type of Study: Clinical Trial

Goal: The goal of this clinical trial is to evaluate the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of HPV infection associated with high-grade cervical disease.

Main Questions:

What is the sensitivity and specificity of molecular HPV assays in detecting high-grade cervical disease (CIN2+) using the DDT compared to a clinician-taken, liquid-based cytology (LBC) sample?

How does the relative sensitivity and specificity of HPV detection in the tampon compare to the LBC sample for the detection of CIN2+?

Participants:

Women attending routine colposcopy clinics as part of standard care.

Main Tasks:

Provide informed consent. Undergo routine colposcopy. Use the DAYE Diagnostic Tampon (DDT). Provide a clinician-taken liquid-based cytology (LBC) sample. Complete a short questionnaire.

Comparison Group:

Researchers will compare the performance of the DAYE Diagnostic Tampon (DDT) to a clinician-taken, liquid-based cytology (LBC) sample to determine if there are differences in sensitivity and specificity for the detection of high-grade cervical disease (CIN2+). The comparison will assess the relative sensitivity and specificity of HPV detection in the tampon versus the LBC sample for the presence/absence of histologically confirmed disease.

Enrollment: 250 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals aged 25-65 years (inclusive)
• Ability to understand patient information sheet
• Ability to provide informed consent
• Natal female
• Referred to colposcopy for routine indications
• In-tact cervix

Exclusion criteria

• <25 years of age or over 65 years of age
• Hysterectomised
• Known allergy or sensitivity to tampons
• Pregnancy (current) or within last 3 months
• History of toxic shock syndrome
• Concurrent participation in other interventional research project

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Main Study Arm

Experimental group

Description:

Women attending for routine colposcopy clinics as part of standard of care will be provided with the opportunity to participate and get tested with the Daye Diagnostic Tampon. Initial notice of the study will be via a patient information sheet sent with the colposcopy invitation

Treatment:

Device: Daye Diagnostic Tampon