HPV E6/E7 mRNA Versus HPV DNA as Triage for Cervical Cancer Screening (PODBT)
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|ClinicalTrials.gov Identifier: NCT02116920|
Recruitment Status : Unknown
Verified April 2014 by Dr Sharmila Pimple, Tata Memorial Hospital.
Recruitment status was: Recruiting
First Posted : April 17, 2014
Last Update Posted : April 17, 2014
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
- 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.
- 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.
- 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.
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.
|Condition or disease|
|CIN Cervix Cancer|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official 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|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
Those patients having acetowhite lesion over cervix on visual inspection after application of acetic acid
- Efficacy Outcome Measure [ Time Frame: 3 Years ]
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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116920
|Contact: Sharmila A Pimple, Professorfirstname.lastname@example.org|
|Contact: Tanuja R Teni, SciOffFemail@example.com|
|Tata Memorial Hospital||Recruiting|
|Mumbai, Maharashtra, India, 400012|
|Contact: Sharmila A Pimple, Professor +912224154379 firstname.lastname@example.org|
|Contact: Tanuja R Teni, SciOffF +912227405071 email@example.com|
|Principal Investigator:||Sharmila A Pimple, Professor||TMH, Tata Memorial Centre, Mumbai|
|Principal Investigator:||Tanuja R Teni, SciOfficerF||ACTREC, Tata Memorial Centre, Mumbai|
|Principal Investigator:||Gauravi A Mishra, Assoc Prof||TMH, Tata Memorial Centra, Mumbai|
|Principal Investigator:||Surendra S Shastri, HOD||TMH, Tata Memorial Centre, Mumbai|