HPV-062 EXT:015

• Research type

  Research Study

• Full title

  A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

• IRAS ID

  52375

• Contact name

  Anne Szarewski

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2009-017282-35

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The HPV-062 study is a 4 year gynaecological follow-up for women from the HPV015 study who were either: - pregnant at their final visit (& so unable to have a cervical sample taken) or- whose cervix was healthy, but tested positive for high-risk human papilloma virus (HPV) infection at their last study visit. This could be visit 9, visit 11 or the last study visit in HPV-015 planned under protocol amendment 4. Both studies are funded by GlaxoSmithKline (GSK) High-risk HPV Infection can lead to changes in the cells of the cervix and ultimately cancer if undetected. This study will offer these women annual cervical screening and treatment if required. There will be one visit every year for up to four years. Each visit will involve a gynaecological examination & cervical cytology test (for high-risk HPV infection & abnormal cells in the cervix). If the tests are abnormal, the clinical management algorithm will be followed and colposcopy and treatment performed according to local medical practice.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/31

• Date of REC Opinion

  7 Jul 2010

• REC opinion

  Further Information Favourable Opinion