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HPV E6/E7 mRNA Versus HPV DNA as Triage for Cervical Cancer Screening

NCT02116920 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2014-04-17

No results posted yet for this study

Summary

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.

Conditions

  • CIN
  • Cervix Cancer

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Sharmila A Pimple, Professor · TMH, Tata Memorial Centre, Mumbai

  • Tanuja R Teni, SciOfficerF · ACTREC, Tata Memorial Centre, Mumbai

  • Gauravi A Mishra, Assoc Prof · TMH, Tata Memorial Centra, Mumbai

  • Surendra S Shastri, HOD · TMH, Tata Memorial Centre, Mumbai

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116920 on ClinicalTrials.gov