Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Neoplasms, Uterine Cervix

Cervical Cancer

Eligibility:

FEMALE

21+ years

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01221987

Start Date

October 1 2009

End Date

September 1 2010

Last Update

April 30 2012

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