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

NCT06210074 | Not Yet Recruiting

• 1 other identifier: PETAHG-ED-001
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

CIN2

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity (%) of the tampon-assay combination & LBC assay combination for detection of histologically high grade disease

  To assess the sensitivity and specificity of molecular HPV assays for the detection of high grade cervical disease (defined as cervical intraepithelial neoplasia grade 2 or worse, CIN2+) using the DDT AND a clinician taken, liquid based cytology (LBC) sample

  end of study (12 months from start)

• Relative sensitivity of the tampon-assay combination vs the LBC-assay combination

  To determine the relative sensitivity and specificity of HPV detection in the tampon vs the LBC sample for the detection of CIN2+.

  end of study (12 months from start)

Secondary Outcomes (2)

• Attitudes to using the Diagnostic Tampon

  up to 24 weeks

• Assessment of Participation Willingness in Research on Tampon-Based Microbial Testing Among Colposcopy Patients

  up to 24 weeks

Study Arms (1)

Main Study Arm

EXPERIMENTAL

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

Device: Daye Diagnostic Tampon

Interventions

Daye Diagnostic Tampon DEVICE

The DAYE Diagnostic Tampon is a class A in vitro diagnostic device. It has CE certification (self-certified via a declaration of conformity, following the IVDR (EU) 2017/746). The DDT is constructed entirely from woven cotton and consists of an absorbent core wrapped in a protective sleeve. The DDT is loaded in an applicator to aid with insertion. The DDT needs to be worn for 20 minutes then when removed should be placed immediately in the sterile container.

Main Study Arm

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Tampon Innovations Ltd: lead
• University of Edinburgh: collaborator
• NHS Lothian: collaborator

Study Officials

• Kate Cuscieri

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Gomes

CONTACT

+447817868946; michelle.gomes@yourdaye.com

Iva Lazarova

CONTACT

iva.lazarova@yourdaye.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 18, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02