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

N/ACompletedNCT01221987

GlaxoSmithKline40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neoplasms, Uterine Cervix Cervical Cancer

Interventions

Cervical samplingPROCEDURE

Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types

Data collectionOTHER

Questionnaire completion

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Up to 12 months from the date of study initiation

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Up to 12 months from the date of study initiation

Data from ClinicalTrials.gov

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