Cervical CancersPaPCRNCT06919627
Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ? (PaPCR)
An observational study of Cervical Cancers and Papillomavirus Infections, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of this retrospective, single-center, observational study is to improve the diagnosis and interpretation of cervical cancer by better detection of epithelial lesions in the case of a late HPV PCR amplification signal rendered negative by routine laboratory testing using GeneXpert® technology. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancers, Papillomavirus Infections, Papillomavirus Type 16/18 Infection
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2025to 30 Jan 2026
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had a PCR HPV test with a late amplification signal in GeneXpert® and were found to be negative.
Who may be able to join
- Patients whose cervico-uterine swab was initially rendered negative by the GeneXpert® system when a late Ct signal (>35) was present in the raw result.
Who cannot join
- Patients with a positive cervico-uterine swab for Papillomavirus.
- Patients with a negative test with no amplification signal.
- Patients who have expressed opposition to inclusion in the study.
- Patients under legal protection (guardianship, curatorship, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ?
The aim of this retrospective, single-center, observational study is to improve the diagnosis and interpretation of cervical cancer by better detection of epithelial lesions in the case of a late HPV PCR amplification signal rendered negative by routine laboratory testing using GeneXpert® technology.
The various evaluation criteria are :
- Presence or absence of lesions on cytological control following a negative HPV test with a late amplification signal on cervico-uterine and anal smear samples from patients seen in consultation at Brest University Hospital from 01/01/2022 to 30/06/2024 (after conventional PCR and genotyping).
- Comparison of the GeneXpert® technique with the results of another conventional pan-genotypic Papillomavirus PCR test.
Read the detailed description
Cervical cancer is the fourth most common cancer in women worldwide, with 660,000 new cases and 350,000 related deaths by 2022. Papillomavirus (HPV) infection is the most common sexually transmitted infection in the world, and is transmitted by mucocutaneous contact. Incidence is particularly high in low- and middle-income countries, due to inadequate access to screening, treatment and vaccination against human papillomavirus (HPV). Numerous genotypes exist worldwide, some of which have oncogenic potential, principally genotypes 16, 18 and 45 (77% of all cervical cancers), and which should be screened as a priority by PCR.
In France, screening varies according to women's age: between the ages of 25 and 29, cytological examination is recommended every 3 years, following two initial tests carried out 1 year apart with normal results. Between the ages of 30 and 35, PCR detection of HPV at high risk of malignancy (HPV-HR) replaces cytological testing. This test is performed 3 years after the last normal cytological examination, and repeated every 5 years. If the PCR is positive, a cytological examination is performed. If the result is negative, a new PCR test is performed 1 year later.
The HPV test based on Cepheid® GeneXpert® technology detects HPV DNA, distinguishing between HPV 16 and 18/45, as well as other high-risk HPVs (31, 33, 35, 52, 58, 51, 59, 39, 56, 66, 68). The test targets E6/E7 oncogenes, and includes a sample adequacy check confirming the presence of human DNA in the sample. This quantitative real-time PCR test can provide quantitative information on viral load. A high viral load is a marker of persistent HPV infection, as well as a risk indicator for squamous intraepithelial lesions (SILs). However, the significance of low viral loads remains unclear.
GeneXpert® technology can produce "negative" results when late amplification (Ct approx. >37) is visible on qPCR curves.
It is difficult for medical biologists to biologically validate an uncertain result, so the aim of this study was to determine the significance of these late amplification curves using cytology results, as well as comparing GeneXpert® technology with in-house real-time PCR and genotyping in the event of positive samples.
- Keywords
- papillomavirus, cancer, virology, PCR, GeneXpert, cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCR HPV test with a late amplification signal in GeneXpert® : negative | Patients whose cervico-uterine sample was initially negative on the GeneXpert® system, but who had a late Ct signal (>35) on the initial gross result. Inclusion period: 01/01/2022 to 06/30/2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
in years
Measured: 3 years
Date of sampling
DD/MM/YYYY
Measured: 3 years
Cytology of sample
presence or absence of intraepithelial lesions
Measured: 3 years
Clinical history
history of intraepithelial lesions or previous HPV test
Measured: 10 years
Conization of lesions
yes or no
Measured: 3 years
Treatment
yes or no
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 posted9 Apr 2025
- Study start27 Mar 2025
- Primary completion14 Apr 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher PAYAN, PU-PH, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919627
- Sponsor's protocol ID
- 29BRC25.0053 - PaPCR
- Acronym
- PaPCR
- Status last verified
- Mar 2025
- First submitted
- 2 Apr 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ?
- ClinicalTrials.gov ID
- NCT06919627
- Acronym / sponsor ID
- PaPCR / 29BRC25.0053 - PaPCR
- Keywords
- papillomavirus, cancer, virology, PCR, GeneXpert, cervical cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 9 Apr 2025 (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.
The aim of this retrospective, single-center, observational study is to improve the diagnosis and interpretation of cervical cancer by better detection of epithelial lesions in the case of a late HPV PCR amplification signal rendered negative by routine laboratory testing using GeneXpert® technology.
The various evaluation criteria are :
- Presence or absence of lesions on cytological control following a negative HPV test with a late amplification signal on cervico-uterine and anal smear samples from patients seen in consultation at Brest University Hospital from 01/01/2022 to 30/06/2024 (after conventional PCR and genotyping).
- Comparison of the GeneXpert® technique with the results of another conventional pan-genotypic Papillomavirus PCR test.
Detailed description
Cervical cancer is the fourth most common cancer in women worldwide, with 660,000 new cases and 350,000 related deaths by 2022. Papillomavirus (HPV) infection is the most common sexually transmitted infection in the world, and is transmitted by mucocutaneous contact. Incidence is particularly high in low- and middle-income countries, due to inadequate access to screening, treatment and vaccination against human papillomavirus (HPV). Numerous genotypes exist worldwide, some of which have oncogenic potential, principally genotypes 16, 18 and 45 (77% of all cervical cancers), and which should be screened as a priority by PCR.
In France, screening varies according to women's age: between the ages of 25 and 29, cytological examination is recommended every 3 years, following two initial tests carried out 1 year apart with normal results. Between the ages of 30 and 35, PCR detection of HPV at high risk of malignancy (HPV-HR) replaces cytological testing. This test is performed 3 years after the last normal cytological examination, and repeated every 5 years. If the PCR is positive, a cytological examination is performed. If the result is negative, a new PCR test is performed 1 year later.
The HPV test based on Cepheid® GeneXpert® technology detects HPV DNA, distinguishing between HPV 16 and 18/45, as well as other high-risk HPVs (31, 33, 35, 52, 58, 51, 59, 39, 56, 66, 68). The test targets E6/E7 oncogenes, and includes a sample adequacy check confirming the presence of human DNA in the sample. This quantitative real-time PCR test can provide quantitative information on viral load. A high viral load is a marker of persistent HPV infection, as well as a risk indicator for squamous intraepithelial lesions (SILs). However, the significance of low viral loads remains unclear.
GeneXpert® technology can produce "negative" results when late amplification (Ct approx. >37) is visible on qPCR curves.
It is difficult for medical biologists to biologically validate an uncertain result, so the aim of this study was to determine the significance of these late amplification curves using cytology results, as well as comparing GeneXpert® technology with in-house real-time PCR and genotyping in the event of positive samples.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCR HPV test with a late amplification signal in GeneXpert® : negative | – | –Patients whose cervico-uterine sample was initially negative on the GeneXpert® system, but who had a late Ct signal (>35) on the initial gross result. Inclusion period: 01/01/2022 to 06/30/2024 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had a PCR HPV test with a late amplification signal in GeneXpert® and were found to be negative.
Key inclusion criteria (1 listed)
- Patients whose cervico-uterine swab was initially rendered negative by the GeneXpert® system when a late Ct signal (>35) was present in the raw result.
Key exclusion criteria (4 listed)
- Patients with a positive cervico-uterine swab for Papillomavirus.
- Patients with a negative test with no amplification signal.
- Patients who have expressed opposition to inclusion in the study.
- Patients under legal protection (guardianship, curatorship, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age
Time frame: 3 years
in years
Date of sampling
Time frame: 3 years
DD/MM/YYYY
Cytology of sample
Time frame: 3 years
presence or absence of intraepithelial lesions
Clinical history
Time frame: 10 years
history of intraepithelial lesions or previous HPV test
Conization of lesions
Time frame: 3 years
yes or no
Treatment
Time frame: 3 years
yes or no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Christopher PAYAN, PU-PH principal investigator
CHU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancers and Papillomavirus Infections, run by University Hospital, Brest at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 2 Apr 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Age (time frame: 3 years). The study lists 6 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 2 Apr 2026.