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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221987
First Posted: October 18, 2010
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Neoplasms, Uterine Cervix Cervical Cancer Procedure: Cervical sampling Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Biospecimen Retention:   Samples With DNA
Tissue samples of invasive cervical cancer

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Females > 21 years of age, diagnosed with invasive cervical cancer
Procedure: Cervical sampling
Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
Other: Data collection
Questionnaire completion
Cohort B
Females > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia
Procedure: Cervical sampling
Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
Other: Data collection
Questionnaire completion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females > 21 years of age, diagnosed with invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221987


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01221987     History of Changes
Other Study ID Numbers: 110430
First Submitted: October 14, 2010
First Posted: October 18, 2010
Last Update Posted: April 30, 2012
Last Verified: May 2011

Keywords provided by GlaxoSmithKline:
Human papillomavirus
neoplasia

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type


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