Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens

NCT02634190 | Completed

• 1 other identifier: Aptima Study
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Human Papilloma Virus Infection

Keywords

Cervical cancer screening; High risk Human Papillomavirus; Aptima HPV Assay

Outcome Measures

Primary Outcomes (1)

• Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test

  Baseline

Secondary Outcomes (8)

• Sensitivity of LBC, HC2® and APTIMA® tests

  Baseline, 5 years

• Specificity of LBC, HC2® and APTIMA® tests

  Baseline, 5 years

• Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests

  Baseline

• Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests

  Baseline

• Prevalence of HR HPV infection by age with HC2® and APTIMA

  Baseline, 5 years

Other Outcomes (2)

• Determination of longitudinal negative predictive value of HPV infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period

  5 years

• Cumulative risk of Human Papilloma Virus (HPV) infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period

  5 years

Study Arms (2)

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

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

Other: Thinprep® LBC; Other: APTIMA® HPV Assay; Other: HR HC2® HPV DNA; Other: Colposcopy

Interventions

Thinprep® LBC OTHER

liquid based cytology

Triple negative women; Women tested positive

APTIMA® HPV Assay OTHER

in vitro diagnostic test

Triple negative women; Women tested positive

HR HC2® HPV DNA OTHER

in vitro diagnostic test

Triple negative women; Women tested positive

Colposcopy OTHER

Colposcopy

Triple negative women; Women tested positive

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women 30 years of age or older coming for routine cervical screening are enrolled in gynaecological practices.

You may qualify if:

• Women aged 30 - 60 years
• Women attending gynaecological practices for routine screening
• Women who gave informed consent to participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic Deutschland GmbH: lead
• University Hospital Tuebingen: collaborator

Related Publications (2)

• 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.

  PMID: 26019212 RESULT

• Iftner 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.

  PMID: 30355760 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

liquid based cytology LBC Specimens (ThinPrep® Pap Test)

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Thomas Iftner, Prof.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 17, 2015
• Study Start: June 1, 2009
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share