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

• 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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]

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.

Females > 21 years of age, diagnosed with invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe

• Neoplasms, Uterine Cervix
• Cervical Cancer

• Procedure: Cervical sampling
  Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
• Other: Data collection
  Questionnaire completion

• Cohort A
  Females > 21 years of age, diagnosed with invasive cervical cancer
  Interventions:

  • Procedure: Cervical sampling
  • Other: Data collection
• Cohort B
  Females > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia
  Interventions:

  • Procedure: Cervical sampling
  • Other: Data collection

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.