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

NCT ID: NCT01221987

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms, Uterine Cervix Cervical Cancer

Keywords

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Human papillomavirus neoplasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort A

Females \> 21 years of age, diagnosed with invasive cervical cancer

Cervical sampling

Intervention Type PROCEDURE

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

Data collection

Intervention Type OTHER

Questionnaire completion

Cohort B

Females \> 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia

Cervical sampling

Intervention Type PROCEDURE

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

Data collection

Intervention Type OTHER

Questionnaire completion

Interventions

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Cervical sampling

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

Intervention Type PROCEDURE

Data collection

Questionnaire completion

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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Sri Lanka

References

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Karunaratne K, Ihalagama H, Rohitha S, Molijn A, Gopala K, Schmidt JE, Chen J, Datta S, Mehta S. Human papillomavirus prevalence and type-distribution in women with cervical lesions: a cross-sectional study in Sri Lanka. BMC Cancer. 2014 Feb 21;14:116. doi: 10.1186/1471-2407-14-116.

Reference Type DERIVED
PMID: 24558979 (View on PubMed)

Other Identifiers

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110430

Identifier Type: -

Identifier Source: org_study_id