Last updated: 11/03/2018 11:02:25
Cross-sectional study on human papillomavirus type distribution in adult women diagnosed with cervical cancer
GSK study ID
110430
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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
Timeframe: Up to 12 months from the date of study initiation
Secondary outcomes:
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
Timeframe: 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
Timeframe: 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
Timeframe: Up to 12 months from the date of study initiation
Interventions:
Enrollment:
40
Primary completion date:
2010-29-09
Observational study model:
Case-Only
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Neoplasms, Uterine Cervix
Product
SB580299
Collaborators
Not applicable
Study date(s)
October 2009 to September 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
21+ years
Accepts healthy volunteers
No
- 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.
- Previous vaccination against human papillomavirus.
- History of chemotherapy or radiotherapy for cervical cancer.
Inclusion and exclusion criteria
Inclusion criteria:
- Histologically confirmed diagnosis of cervix intraepithelial neoplasia
- 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.
A female > 21 years of age at the time of diagnosis of invasive cervical cancer or cervical intraepithelial neoplasia
moderate or severe.
moderate or severe, invasive cervical cancer, glandular lesions and other epithelial tumours.
Exclusion criteria:
- History of chemotherapy or radiotherapy for cervical cancer.
- Subjects with recurrent episodes of invasive cervical cancer or cervical intraepithelial neoplasia- moderate or severe.
Previous vaccination against human papillomavirus.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2010-29-09
Actual study completion date
2010-29-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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