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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


N/A
21 Years
N/A
Not Enrolling
Female
Neoplasms, Uterine Cervix, Cervical Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Up to 12 months from the date of study initiation

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Sri Lanka: Ministry of Healthcare and Nutrition

Study ID:

110430

NCT ID:

NCT01221987

Start Date:

October 2009

Completion Date:

September 2010

Related Keywords:

  • Neoplasms, Uterine Cervix
  • Cervical Cancer
  • Human papillomavirus
  • neoplasia
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Cervical Intraepithelial Neoplasia

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