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

Study Overview
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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.

Official Title
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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

Conditions
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Neoplasms, Uterine Cervix, Cervical Cancer

Intervention / Treatment
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* Procedure: Cervical sampling
* Other: Data collection


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Females > 21 years of age, diagnosed with invasive cervical cancer | Procedure: Cervical sampling<br>* Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types<br>Other: Data collection<br>* Questionnaire completion<br>|
| Cohort B<br>Females > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia | Procedure: Cervical sampling<br>* Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types<br>Other: Data collection<br>* Questionnaire completion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human papillomavirus, neoplasia