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NCT Number: NCT01221987

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

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.

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Key information

Conditions

Neoplasms, Uterine Cervix Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cervical sampling

Procedure

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

Data Collection

Other

Questionnaire completion

Primary outcomes

  1. 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

    Time frame: Up to 12 months from the date of study initiation

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 18, 2010
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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