Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
NCT ID: NCT06210074
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2024-02-29
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Ability to understand patient information sheet
* Ability to provide informed consent
* Natal female
* Referred to colposcopy for routine indications
* In-tact cervix
Exclusion Criteria
* 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
25 Years
65 Years
FEMALE
Yes
Sponsors
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University of Edinburgh
OTHER
NHS Lothian
OTHER_GOV
Tampon Innovations Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Kate Cuscieri
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Central Contacts
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Other Identifiers
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PETAHG-ED-001
Identifier Type: -
Identifier Source: org_study_id
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