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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Females > 21 years of age, diagnosed with invasive cervical cancer |
| |
| Cohort B | Females > 21 years of age, diagnosed with moderate or severe cervical intraepithelial neoplasia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical sampling | Procedure | Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Females > 21 years of age, diagnosed with invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24558979 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Tissue samples of invasive cervical cancer
| Data collection | Other | Questionnaire completion |
|
| 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 |
| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |