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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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01221987
First received: October 14, 2010
Last updated: April 26, 2012
Last verified: May 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221987

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01221987     History of Changes
Other Study ID Numbers: 110430
Study First Received: October 14, 2010
Last Updated: April 26, 2012
Health Authority: Sri Lanka: Ministry of Healthcare and Nutrition

Keywords provided by GlaxoSmithKline:
Human papillomavirus
neoplasia

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

ClinicalTrials.gov processed this record on May 16, 2013