Cervix Cancer Clinical Trial
— PODBTOfficial title:
Evaluation of the Diagnostic Performance of HPV E6/E7 mRNA Versus Oncogenic HPV DNA as a Secondary Triage Test for VIA Positive Women in Cervical Cancer Screening Program
AIM: To develop and standardize a cost effective methodology or algorithm for mRNA E6/E7 for
HPV genotypes 16, 18, 31, 33 and 45 as compared to commercially available assays which can
be incorporated to triage excess false positives from primary screening for cervical cancers
Objectives:
1. Development and standardization of methodology /algorithm for mRNA E6/E7 testing for
HPV genotypes 16, 18, 31, 33 and 45 using Real-time RT-PCR, in cervical samples.
2. To compare the test performance of this HPV E6/E7 mRNA assay to HPV DNA by HC 2 as
secondary screening test, with the reference standard of colposcopy with biopsy, to
triage women found positive in primary screening by VIA , in a population based
screening for cancer of cervix.
3. To determine number of false positives in the primary screening test after testing VIA
positives with a known high specificity secondary screening test (HPV-DNA HC II )
compared to HPV E6/E7 mRNA testing.
Study Population: Women in the age group of 30-65 years, who test positive on primary
cervical screening test VIA will be enrolled for the proposed diagnostic tests along with
reference standard of colposcopy with guided biopsy.
Methodology:
Women in the age group of 30-65 years undergoing routine cervical cancer screening through
hospital ( Preventive Oncology screening clinic) and community based screening programs with
abnormal test result using the primary cervical cancer screening test VIA will be recruited
in the study. The primary screening test VIA will be administered by application of 5%
Acetic Acid to the cervix and visualizing the cervix with the help of a halogen focus lamp.
VIA will be considered to be positive if definite acetowhite lesions are visualized close to
the squamocolumnar junction.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Female between 30-65years of age 2. Not pregnant by menstrual history 3. No history of prior treatment for cancer of the cervix 4. No history of hysterectomy 5. Healthy enough to undergo a pelvic examination, i.e., not seriously ill with a debilitating condition Exclusion Criteria: 1. Women below and above this age group 2. Women already screened and detected for cervical precencers and cancers 3. Women with debilitating condition 4. Women with Hysterectomy 5. Women whom are pregnant |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Hospital | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital | Ministry of Science and Technology, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy Outcome Measure | Sensitivity and specificity of HPV DNA test versus E6/E7 mRNA test against gold standard of histopathology confirmed CINs. After the above mentioned time frame, efficacy of 1. HPV DNA Test and 2. E6/E7 mRNA test will be evaluated. Such evaluation is not applicable for individual participants. |
3 Years | No |
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