Cross-sectional Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Cervical Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort A Females > 21 years of age, diagnosed with invasive cervical cancer |
Procedure: Cervical sampling
Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
Other: Data collection
Questionnaire completion
|
| Cohort B Females > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia |
Procedure: Cervical sampling
Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
Other: Data collection
Questionnaire completion
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 110430