Vulval intraepithelial neoplasia: immune responses to human papillpmavirus. - HPV immunology in VI

• Conditions: Vulval intraepithelial neoplasia; MedDRA version: 9.1Level: LLTClassification code 10056574Term: Vulval intraepithelial neoplasia

• Registration Number: EUCTR2007-006761-32-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Pilot:
Age over 18
Able to give fully informed consent

Study:
Female
Age 18-60
Able to give fully informed consent
Diagnosis of vulval intraepithelial neoplasia (VIN)
Or Diagnosis of inflammatory vulval dermatosis
Or Diagnosis of genital warts
Or Normal vulval skin
Have no known allergy to imiquimod (only patients with VIN for treatment with imiquimod)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Study:
Male
Individuals unable for any reason to give fully informed consent
Age below 18 or over 60 years of age
Immunosuppression
Pregnancy (only patients with VIN for treatment with imiquimod)
Breastfeeding (only patients with VIN for treatment with imiquimod)
Previous vulval carcinoma (only patients with VIN for treatment with imiquimod)
Known allergy to imiquimod (only patients with VIN for treatment with imiquimod)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified