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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221987
• Other study ID #: 110430
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: April 26, 2012
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: Ministry of Healthcare and Nutrition
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Neoplasms, Uterine Cervix
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Procedure:
• Cervical sampling
Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types

Other:
• Data collection
Questionnaire completion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No