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

CIN2 Clinical Trial

— PETAHG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210074
• Other study ID #: PETAHG-ED-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Anne's Day Ltd
• Contact: Michelle Gomes
• Phone: +447817868946
• Email: michelle.gomes[@]yourdaye.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CIN2

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Tampon Innovations Ltd	NHS Lothian, University of Edinburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Attitudes to using the Diagnostic Tampon	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
Secondary	Assessment of Participation Willingness in Research on Tampon-Based Microbial Testing Among Colposcopy Patients	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