Clinical trial NCT01221987: Cross-sectional Study on Human Papillomavirus Type Distribution in Adult Women Diagnosed With Cervical Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Uterine Cervix
Cervical Cancer
Keywords: Human papillomavirus
neoplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females \> 21 years of age, diagnosed with invasive cervical cancer or cervical intraepithelial neoplasia - moderate or severe

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.