Development of a new low cost computer assisted visual Cervical Cancer Screening method
Not Applicable
- Registration Number
- CTRI/2019/11/021904
- Lead Sponsor
- Tata Memorial Center TMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Language: able to speak/understand Hindi or Punjabi.
-Mental competence: apparently mentally competent.
-Provision of written informed consent.
Exclusion Criteria
-Current pregnancy;
-History of cervical cancer;
-History of hysterectomy;
-History of having undergone LEEP or cold-cone partial removal of the cervix;
-Heavy menstrual bleeding (if the woman prefers not to be examined)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Development and internal validation of a deep-learning based algorithm for automated visual evaluation (AVE) of cervical images captured through a mobile phone for the identification of histopathologically confirmed CIN3+/AIS for: 1) primary screening and 2) triage of HPV-positive women for colposcopy <br/ ><br>Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method -Sensitivity & specificity of AVE algorithm as a primary screening method and as a triage-method for HPV-positive women in the internal validation set <br/ ><br>-Prevalence & carcinogenicity of specific HPV genotypes/variants by host ancestry <br/ ><br>-Association of vaginal microbiome with cervicitis <br/ ><br>-Sensitivity & specificity of the viral methylation marker assays as a triage test for detecting precancer in vaginal specimenTimepoint: 12 months