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

Hologic

Status: Completed

Conditions: Human Papilloma Virus Infection

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02634190

Aptima Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

10,000 participants in 2 patient groups

Triple negative women

Description:

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

Treatment:

Other: APTIMA® HPV Assay

Other: Thinprep® LBC

Other: Colposcopy

Other: HR HC2® HPV DNA

Women tested positive

Description:

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

Treatment:

Other: APTIMA® HPV Assay

Other: Thinprep® LBC

Other: Colposcopy

Other: HR HC2® HPV DNA