Cross-sectional Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Cervical Cancer

Completed

• Conditions: Neoplasms, Uterine Cervix; Cervical Cancer
• Interventions: Procedure: Cervical sampling; Other: Data collection

• Registration Number: NCT01221987
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The current study will elucidate the human papillomavirus type distribution in a population of women diagnosed with cervical high grade pre-cancerous lesions and invasive cervical cancer in Sri Lanka.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Status Verified: 2011-05
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• A female > 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe.
• Histologically confirmed diagnosis of cervix intraepithelial neoplasia - moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
• Written informed consent obtained from the subject prior to study start.
• Subjects who the investigator believes can and will comply with the requirements of the protocol, should be enrolled in the study.

Exclusion Criteria

• Previous vaccination against human papillomavirus.
• History of chemotherapy or radiotherapy for cervical cancer.
• Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	Data collection	Females \> 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia
Cohort A	Cervical sampling	Females \> 21 years of age, diagnosed with invasive cervical cancer
Cohort A	Data collection	Females \> 21 years of age, diagnosed with invasive cervical cancer
Cohort B	Cervical sampling	Females \> 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia

Primary Outcome Measures

Name	Time	Method
Detection of human papillomavirus-16, human papillomavirus-18 in invasive cervical cancer and cervix intraepithelial neoplasia- moderate or cervix intraepithelial neoplasia- severe by short PCR fragment polymerase chain reaction and line probe assay	Up to 12 months from the date of study initiation

Secondary Outcome Measures

Name	Time	Method
Detection of other high risk types in invasive cervical cancer and cervical intraepithelial neoplasia moderate or severe by short PCR fragment polymerase chain reaction and line probe assay	Up to 12 months from the date of study initiation
Occurrence of human papillomavirus-16, human papillomavirus-18 or other high risk types in relation to covariates	Up to 12 months from the date of study initiation
Detection of co-infection of human papillomavirus-16 and human papillomavirus-18 in relation to other high risk types	Up to 12 months from the date of study initiation