NCT01221987

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

April 30, 2012

Status Verified

May 1, 2011

Enrollment Period

11 months

First QC Date

October 14, 2010

Last Update Submit

April 26, 2012

Conditions

Neoplasms, Uterine CervixCervical Cancer

Keywords

Human papillomavirusneoplasia

Outcome Measures

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

    Up to 12 months from the date of study initiation

Secondary Outcomes (3)

  • 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

    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

    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

    Up to 12 months from the date of study initiation

Study Arms (2)

Cohort A

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

Procedure: Cervical samplingOther: Data collection

Cohort B

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

Procedure: Cervical samplingOther: Data collection

Interventions

Cervical samplingPROCEDURE

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

Cohort ACohort B
Data collectionOTHER

Questionnaire completion

Cohort ACohort B

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24558979DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples of invasive cervical cancer

MeSH Terms

Conditions

NeoplasmsUterine Cervical Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 18, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 30, 2012

Record last verified: 2011-05