Human Papilloma Virus InfectionNCT02634190
Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens
An observational study of Human Papilloma Virus Infection, run by Hologic Deutschland GmbH.
Trial summary
To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection
- What is being tested?
- Thinprep® LBC, APTIMA® HPV Assay and HR HC2® HPV DNA
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2021
- 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women 30 years of age or older coming for routine cervical screening are enrolled in gynaecological practices.
Who may be able to join
- Women aged 30 - 60 years
- Women attending gynaecological practices for routine screening
- Women who gave informed consent to participation in the study
Who cannot join
- Women with hysterectomy or known destructive therapy to the cervix
- Women who are pregnant
- Women with an abnormal cytology result during the previous 6 months
- Women with known HIV infection or history of transplants
- Women vaccinated against HPV
- Women participating in another research protocol
About this study
Official title: Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HPV HC2® Test in Women 30 Years of Age or Older Using LBC ThinPrep® Pap Test Specimens
To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.
Read the detailed description
The study is conducted in the areas of Tuebingen, Freiburg and Saarbruecken in Germany. In total, 10.000 ThinPrep® LBC cervical samples were collected from June 2009 to May 2012. Liquid based cytology (LBC) was performed by a central laboratory in Saarbruecken. Human papilloma virus (HPV) testing with the HR HPV HC2® test and APTIMA® HPV Assay were performed at the Section of Experimental Virology, Institute of Medical Virology, University Clinic of Tuebingen, Germany (UKT).
Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years.
Study close out visit: In addition, approximately 5 years after baseline ThinPrep® LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (NPV) and HPV related disease after a 5 year period. Women who tested positive in any test will undergo colposcopy.
- Conditions
- Human Papilloma Virus Infection
- Being tested
- Thinprep® LBC, APTIMA® HPV Assay, HR HC2® HPV DNA, Colposcopy
- Keywords
- Cervical cancer screening, High risk Human Papillomavirus, Aptima HPV Assay
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinprep® LBCOther
liquid based cytology
APTIMA® HPV AssayOther
in vitro diagnostic test
HR HC2® HPV DNAOther
in vitro diagnostic test
ColposcopyOther
Colposcopy
| Study group | Role | What they receive |
|---|---|---|
| Triple negative women | Women 30 years of age or older coming for routine cervical screening who tested triple negative at baseline with the interventions: Thinprep® LBC, HR HC2® HPV DNA and APTIMA® HPV Assay Receives: Other: Thinprep® LBC; Other: APTIMA® HPV Assay; Other: HR HC2® HPV DNA; Other: Colposcopy | |
| Women tested positive | Women who tested positive in any of the tests Thinprep® LBC, HR HC2® HPV DNA or APTIMA® HPV Assay will undergo colposcopy and be followed up over a ten year period and subjects who tested positive during the follow up assessment will be followed up over a 5 year period on a yearly basis Receives: Other: Thinprep® LBC; Other: APTIMA® HPV Assay; Other: HR HC2® HPV DNA; Other: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test
Measured: Baseline
Secondary outcomes (8)
Sensitivity of LBC, HC2® and APTIMA® tests
Measured: Baseline, 5 years
Specificity of LBC, HC2® and APTIMA® tests
Measured: Baseline, 5 years
Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests
Measured: Baseline
Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests
Measured: Baseline
Prevalence of HR HPV infection by age with HC2® and APTIMA
Measured: Baseline, 5 years
Cross sectional association between HR HPV infection (HC2® and APTIMA) and LBC diagnosis
Linear regression models will be used for determination of cross sectional associations between HR HPV Infection and LBC diagnosis.
Measured: Baseline, 5 years
Relative risk of cervical disease for positive tested women
Analysis of study results at baseline and follow-up visits. Calculation of relative risks of cervical disease for women who are positive for LBC, HC2® and/or APTIMA® test compared to those being negative for any of the three tests at the baseline visit.
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Cumulative risk of cervical diseases for positive tested women at 5 years
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJun 2009
- Primary completionJun 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Thomas Iftner, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634190
- Sponsor's protocol ID
- Aptima Study
- Status last verified
- Feb 2024
- First submitted
- 3 Dec 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Iftner T, Becker S, Neis KJ, Castanon A, Iftner A, Holz B, Staebler A, Henes M, Rall K, Haedicke J, von Weyhern CH, Clad A, Brucker S, Sasieni P. Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany. J Clin Microbiol. 2015 Aug;53(8):2509-16. doi: 10.1128/JCM.01013-15. Epub 2015 May 27.
PubMed 26019212Iftner T, Neis KJ, Castanon A, Landy R, Holz B, Woll-Herrmann A, Iftner A, Staebler A, Wallwiener D, Hann von Weyhern C, Neis F, Haedicke-Jarboui J, Martus P, Brucker S, Henes M, Sasieni P. Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany. J Clin Microbiol. 2019 Jan 2;57(1):e01177-18. doi: 10.1128/JCM.01177-18. Print 2019 Jan.
PubMed 30355760
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HPV HC2® Test in Women 30 Years of Age or Older Using LBC ThinPrep® Pap Test Specimens
- ClinicalTrials.gov ID
- NCT02634190
- Acronym / sponsor ID
- Aptima Study
- Conditions
- Human Papilloma Virus Infection
- Keywords
- Cervical cancer screening, High risk Human Papillomavirus, Aptima HPV Assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Hologic Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen
- Study start
- Jun 2009
- Primary completion
- Jun 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 17 Dec 2015 (estimated)
- 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.
To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.
Detailed description
The study is conducted in the areas of Tuebingen, Freiburg and Saarbruecken in Germany. In total, 10.000 ThinPrep® LBC cervical samples were collected from June 2009 to May 2012. Liquid based cytology (LBC) was performed by a central laboratory in Saarbruecken. Human papilloma virus (HPV) testing with the HR HPV HC2® test and APTIMA® HPV Assay were performed at the Section of Experimental Virology, Institute of Medical Virology, University Clinic of Tuebingen, Germany (UKT).
Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years.
Study close out visit: In addition, approximately 5 years after baseline ThinPrep® LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (NPV) and HPV related disease after a 5 year period. Women who tested positive in any test will undergo colposcopy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple negative women | – | Other: Thinprep® LBC, Other: APTIMA® HPV Assay, Other: HR HC2® HPV DNA, Other: ColposcopyWomen 30 years of age or older coming for routine cervical screening who tested triple negative at baseline with the interventions: Thinprep® LBC, HR HC2® HPV DNA and APTIMA® HPV Assay |
| Women tested positive | – | Other: Thinprep® LBC, Other: APTIMA® HPV Assay, Other: HR HC2® HPV DNA, Other: ColposcopyWomen who tested positive in any of the tests Thinprep® LBC, HR HC2® HPV DNA or APTIMA® HPV Assay will undergo colposcopy and be followed up over a ten year period and subjects who tested positive during the follow up assessment will be followed up over a 5 year period on a yearly basis |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women 30 years of age or older coming for routine cervical screening are enrolled in gynaecological practices.
Key inclusion criteria (3 listed)
- Women aged 30 - 60 years
- Women attending gynaecological practices for routine screening
- Women who gave informed consent to participation in the study
Key exclusion criteria (6 listed)
- Women with hysterectomy or known destructive therapy to the cervix
- Women who are pregnant
- Women with an abnormal cytology result during the previous 6 months
- Women with known HIV infection or history of transplants
- Women vaccinated against HPV
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 |
|---|---|---|
| Thinprep® LBCliquid based cytology | Other | Triple negative women, Women tested positive |
| APTIMA® HPV Assayin vitro diagnostic test | Other | Triple negative women, Women tested positive |
| HR HC2® HPV DNAin vitro diagnostic test | Other | Triple negative women, Women tested positive |
| ColposcopyColposcopy | Other | Triple negative women, Women tested positive |
Primary outcome
Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test
Time frame: Baseline
8 secondary outcomes
Sensitivity of LBC, HC2® and APTIMA® tests
Time frame: Baseline, 5 years
Specificity of LBC, HC2® and APTIMA® tests
Time frame: Baseline, 5 years
Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests
Time frame: Baseline
Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests
Time frame: Baseline
Prevalence of HR HPV infection by age with HC2® and APTIMA
Time frame: Baseline, 5 years
Cross sectional association between HR HPV infection (HC2® and APTIMA) and LBC diagnosis
Time frame: Baseline, 5 years
Relative risk of cervical disease for positive tested women
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Cumulative risk of cervical diseases for positive tested women at 5 years
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
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 28 Feb 2024.
- Results publication: PubMed 26019212Iftner T, Becker S, Neis KJ, Castanon A, Iftner A, Holz B, Staebler A, Henes M, Rall K, Haedicke J, von Weyhern CH, Clad A, Brucker S, Sasieni P. Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany. J Clin Microbiol. 2015 Aug;53(8):2509-16. doi: 10.1128/JCM.01013-15. Epub 2015 May 27.
- Results publication: PubMed 30355760Iftner T, Neis KJ, Castanon A, Landy R, Holz B, Woll-Herrmann A, Iftner A, Staebler A, Wallwiener D, Hann von Weyhern C, Neis F, Haedicke-Jarboui J, Martus P, Brucker S, Henes M, Sasieni P. Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany. J Clin Microbiol. 2019 Jan 2;57(1):e01177-18. doi: 10.1128/JCM.01177-18. Print 2019 Jan.
- 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.
Thomas Iftner, Prof. principal investigator
University Hospital Tuebingen
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus Infection, run by Hologic Deutschland GmbH.
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 3 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: finished, as of the sponsor's last update on 28 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?
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?
Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634190, which also lists 2 linked publications.
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 28 Feb 2024.