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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
Sponsor:
Collaborator:
Ministry of Science and Technology, India
Information provided by (Responsible Party):
Dr Sharmila Pimple, Tata Memorial Hospital

Brief 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.


Condition or disease
CIN Cervix Cancer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort
VIA Positive
Those patients having acetowhite lesion over cervix on visual inspection after application of acetic acid



Primary Outcome Measures :
  1. 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
Cervical Biopsy and Endo-cervical Brushing


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women in the age group of 30 to 65 years (non pregnant and with intact uterus) in urban slum colonies of Mumbai city
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Sharmila A Pimple, Professor +912224154379 drsharmilapatil@yahoo.com
Contact: Tanuja R Teni, SciOffF +912227405071 tteni@actrec.gov.in

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Sharmila A Pimple, Professor    +912224154379    drsharmilapatil@yahoo.com   
Contact: Tanuja R Teni, SciOffF    +912227405071    tteni@actrec.gov.in   
Sponsors and Collaborators
Tata Memorial Hospital
Ministry of Science and Technology, India
Investigators
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

Additional Information:
Responsible Party: Dr Sharmila Pimple, Professor in Preventive Oncology, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02116920     History of Changes
Other Study ID Numbers: BT/PR6121/SPD/11/1401/2012
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by Dr Sharmila Pimple, Tata Memorial Hospital:
CIN
HPV DNA
mRNA E6/E7
CIN triage
Cervix Biopsy
VIA
Cervix Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female