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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Neoplasms, Uterine Cervix; Cervical Cancer

Treatments: Procedure: Cervical sampling; Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01221987

110430

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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.

Trial design

40 participants in 2 patient groups

Cohort A

Description:

Females \> 21 years of age, diagnosed with invasive cervical cancer

Treatment:

Other: Data collection

Procedure: Cervical sampling

Cohort B

Description:

Females \> 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia

Treatment:

Other: Data collection

Procedure: Cervical sampling