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

February 12, 2024 updated by: Tampon Innovations Ltd
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main Study Arm
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity (%) of the tampon-assay combination & LBC assay combination for detection of histologically high grade disease
Time Frame: end of study (12 months from start)
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
Time Frame: end of study (12 months from start)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitudes to using the Diagnostic Tampon
Time Frame: up to 24 weeks
Reponses/scores derived from brief questionnaire to assess the attitudes of the study recruits to the use of the DDT for HPV sampling
up to 24 weeks
Assessment of Participation Willingness in Research on Tampon-Based Microbial Testing Among Colposcopy Patients
Time Frame: up to 24 weeks
Quantification of Participation Rates: A comparison between the number of colposcopy patients invited to participate and those who actively engaged in research. This study aims to determine the level of willingness within the colposcopy population to partake in research focused on the utilization of tampons for microbial testing. The outcome measure will specifically assess the percentage of invited participants who actively contribute to the study, shedding light on the feasibility and acceptance of the proposed research intervention within this demographic. This quantification will be instrumental in understanding the potential for successful recruitment and engagement in future studies involving tampon-based microbial testing.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampon Innovations Ltd

Collaborators

University of Edinburgh
NHS Lothian

Investigators

  • Principal Investigator: Kate Cuscieri, NHS Lothian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PETAHG-ED-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on CIN2

Clinical Trials on Daye Diagnostic Tampon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe