Cervical CancerNCT03721484
CINtec PLUS Triage in HPV Primary Screening
A study testing CINtec PLUS in people with Cervical Cancer, run by Western Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Prospective study which will recruit participants when they attend for a routine cervical screening. The study will evaluate the use of CINtec PLUS for triage of human papillomavirus (HPV) positive participants in HPV primary screening. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- CINtec PLUS
- How many people
- 9,800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2019to Dec 2021
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consenting women aged 25y-64y attending for cervical screening
Who cannot join
- Women aged <25y and >64y
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CINtec PLUS Triage of HPV Positive Women in HPV Primary Screening
Prospective study which will recruit participants when they attend for a routine cervical screening. The study will evaluate the use of CINtec PLUS for triage of human papillomavirus (HPV) positive participants in HPV primary screening.
Read the detailed description
The study will recruit participants (9800) prospectively by verbal invitation from the sample taker when they attend for their cervical screening test. Recruitment will take up to one year to complete. Participants in the study will undergo primary HPV testing. This will be followed by cervical cytology testing as per the normal National Health Service Cervical Screening Programme (NHSCSP) screening invitation pathway. Participants testing HPV negative will have reached their end point and will exit the study. Participants who test HPV positive will be triaged by cytology (the cytology screening result, available through the NHSCSP screen will be used). Participants with moderate or severe dyskaryosis (high-grade disease) will be immediately referred to colposcopy (as per NHSCSP guidelines) without further testing. Participants with borderline or mild dyskaryosis (low-grade findings) will undergo CINtec PLUS Cytology triage simulation; however, regardless of the CINtec PLUS result, all participants will also be referred to colposcopy as per NHSCSP guidelines. Participants with negative cytology will undergo CINtec PLUS Cytology triage and those testing positive (an indication of increased risk of CIN2+ [high-grade disease]) will be referred to colposcopy. Participants with negative cytology who also test CINtec PLUS negative will only be referred to colposcopy if they have tested positive for HPV16 or HPV18 as these 2 genotypes have been shown to confer an elevated risk for CIN2+ compared with the other HPV types. Participants with negative cytology who also test CINtec PLUS negative and have tested positive for non HPV16 and HPV18 types will undergo repeat HPV testing at 12 months as the low risk of CIN2+ associated with these participants does not justify immediate colposcopy referral and is unlikely to be granted ethical approval.
Clinical outcomes based on colposcopy and/or histology and/or cervical cytology will be recorded. All biopsies will have one slide stained with CINtec Histology (p16). The risk of CIN2+ will be evaluated for all participants in the study. Subsequently, clinical performance of CINtec PLUS Cytology will be evaluated.
This work will also include a cost analysis.
- Conditions
- Cervical Cancer
- Being tested
- CINtec PLUS
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CINtec PLUSDiagnostic test
CINtec PLUS testing will be used to triage HPV positive women to colposcopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of high-grade disease
CIN2+ diagnosed on biopsy obtained at colposcopy.
Measured: 3 years
Risk of low-grade disease
<CIN2 as determined by colposcopy assessment/biopsy or cytology ≤Mild/HPV negative.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study startJan 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Dr. Mary McMenamin, Western Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721484
- Sponsor's protocol ID
- v1.0
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CINtec PLUS Triage of HPV Positive Women in HPV Primary Screening
- ClinicalTrials.gov ID
- NCT03721484
- Acronym / sponsor ID
- v1.0
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,800 participants (estimated)
- Lead sponsor
- Western Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Oct 2018 (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.
Prospective study which will recruit participants when they attend for a routine cervical screening. The study will evaluate the use of CINtec PLUS for triage of human papillomavirus (HPV) positive participants in HPV primary screening.
Detailed description
The study will recruit participants (9800) prospectively by verbal invitation from the sample taker when they attend for their cervical screening test. Recruitment will take up to one year to complete. Participants in the study will undergo primary HPV testing. This will be followed by cervical cytology testing as per the normal National Health Service Cervical Screening Programme (NHSCSP) screening invitation pathway. Participants testing HPV negative will have reached their end point and will exit the study. Participants who test HPV positive will be triaged by cytology (the cytology screening result, available through the NHSCSP screen will be used). Participants with moderate or severe dyskaryosis (high-grade disease) will be immediately referred to colposcopy (as per NHSCSP guidelines) without further testing. Participants with borderline or mild dyskaryosis (low-grade findings) will undergo CINtec PLUS Cytology triage simulation; however, regardless of the CINtec PLUS result, all participants will also be referred to colposcopy as per NHSCSP guidelines. Participants with negative cytology will undergo CINtec PLUS Cytology triage and those testing positive (an indication of increased risk of CIN2+ [high-grade disease]) will be referred to colposcopy. Participants with negative cytology who also test CINtec PLUS negative will only be referred to colposcopy if they have tested positive for HPV16 or HPV18 as these 2 genotypes have been shown to confer an elevated risk for CIN2+ compared with the other HPV types. Participants with negative cytology who also test CINtec PLUS negative and have tested positive for non HPV16 and HPV18 types will undergo repeat HPV testing at 12 months as the low risk of CIN2+ associated with these participants does not justify immediate colposcopy referral and is unlikely to be granted ethical approval.
Clinical outcomes based on colposcopy and/or histology and/or cervical cytology will be recorded. All biopsies will have one slide stained with CINtec Histology (p16). The risk of CIN2+ will be evaluated for all participants in the study. Subsequently, clinical performance of CINtec PLUS Cytology will be evaluated.
This work will also include a cost analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Consenting women aged 25y-64y attending for cervical screening
Key exclusion criteria (1 listed)
- Women aged <25y and >64y
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 |
|---|---|---|
| CINtec PLUSCINtec PLUS testing will be used to triage HPV positive women to colposcopy | Diagnostic test | – |
Primary outcome
Risk of high-grade disease
Time frame: 3 years
CIN2+ diagnosed on biopsy obtained at colposcopy.
Risk of low-grade disease
Time frame: 3 years
<CIN2 as determined by colposcopy assessment/biopsy or cytology ≤Mild/HPV negative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CINtec PLUS in people with Cervical Cancer, run by Western Health and Social Care Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of high-grade disease (time frame: 3 years). 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 26 Oct 2018.