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

A Cross-sectional, Hospital-based, Epidemiological Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) and/or Cervical Intraepithelial Neoplasia (CIN) II and/or CIN III in Sri Lanka

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01221987

Enrollment

Registered

2010-10-18

Start date

2009-10-31

Completion date

2010-09-30

Last updated

2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Neoplasms, Uterine Cervix

Keywords

Human papillomavirus, neoplasia

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.

Interventions

PROCEDURECervical sampling

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

OTHERData collection

Questionnaire completion

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026