CIN2PETAHGNCT06210074
Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
A study testing Daye Diagnostic Tampon in people with CIN2, run by Tampon Innovations Ltd.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CIN2
- What is being tested?
- Daye Diagnostic Tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
No sites are listed yet.
Iva Lazarova contact
About this study
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
Read the 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.
- Conditions
- CIN2
- Being tested
- Daye Diagnostic Tampon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daye Diagnostic TamponDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Daye Diagnostic Tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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+.
Measured: end of study (12 months from start)
Secondary outcomes (2)
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
Measured: up to 24 weeks
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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIN2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampon Innovations Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Edinburgh, NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Kate Cuscieri, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210074
- Sponsor's protocol ID
- PETAHG-ED-001
- Acronym
- PETAHG
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
- ClinicalTrials.gov ID
- NCT06210074
- Acronym / sponsor ID
- PETAHG / PETAHG-ED-001
- Conditions
- CIN2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tampon Innovations LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Edinburgh, NHS Lothian
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Study Arm | Experimental | Device: Daye Diagnostic TamponWomen 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 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daye Diagnostic TamponThe 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. | Device | Main Study Arm |
Primary outcome
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
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+.
2 secondary outcomes
Attitudes to using the Diagnostic Tampon
Time frame: up to 24 weeks
Assessment of Participation Willingness in Research on Tampon-Based Microbial Testing Among Colposcopy Patients
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iva Lazarova contact
Kate Cuscieri principal investigator
NHS Lothian
Questions about this trial
What is this clinical trial studying?
A study testing Daye Diagnostic Tampon in people with CIN2, run by Tampon Innovations Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Gomes (+447817868946, michelle.gomes@yourdaye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.