Clinical trial NCT06210074: Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
Official title: Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CIN2
Lead sponsor: Anne's Day Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Edinburgh
name: NHS Lothian
First posted: 2024-01-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity (%) of the tampon-assay combination & LBC assay combination for detection of histologically high grade disease
timeFrame: end of study (12 months from start)
measure: Relative sensitivity of the tampon-assay combination vs the LBC-assay combination
timeFrame: end of study (12 months from start)
Secondary outcomes:
measure: Attitudes to using the Diagnostic Tampon
timeFrame: up to 24 weeks
measure: Assessment of Participation Willingness in Research on Tampon-Based Microbial Testing Among Colposcopy Patients
timeFrame: up to 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: NHS Lothian
name: Kate Cuscieri
role: PRINCIPAL_INVESTIGATOR
References: