NCT02116920

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. 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

March 25, 2014

Last Update Submit

April 15, 2014

Conditions

CINCervix Cancer

Keywords

CINHPV DNAmRNA E6/E7CIN triageCervix BiopsyVIACervix Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

VIA Positive

Those patients having acetowhite lesion over cervix on visual inspection after application of acetic acid

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Female between 30-65years of age
  • Not pregnant by menstrual history
  • No history of prior treatment for cancer of the cervix
  • No history of hysterectomy
  • Healthy enough to undergo a pelvic examination, i.e., not seriously ill with a debilitating condition

You may not qualify if:

  • Women below and above this age group
  • Women already screened and detected for cervical precencers and cancers
  • Women with debilitating condition
  • Women with Hysterectomy
  • Women whom are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Cervical Biopsy and Endo-cervical Brushing

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmila A Pimple, Professor

CONTACT

+912224154379drsharmilapatil@yahoo.com

Tanuja R Teni, SciOffF

CONTACT

+912227405071tteni@actrec.gov.in

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Preventive Oncology

Study Record Dates

First Submitted

March 25, 2014

First Posted

April 17, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

IN(1)