None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Control Intervention1: HPV testing on all positive samples: HPV testing on all positive samples
Control Intervention2: Manual te
Sponsors
Vyuhaa Med Data Private Limited
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 25-65 with no prior history of cervical cancer. Patients within the screening age range who have undergone a supracervical hysterectomy. Individuals over 65 years old without documented prior screening. Vault smears are recommended for patients with a history of cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
Exclusion criteria
Exclusion criteria: Pregnant women. Women with a known history of cervical cancer or those undergoing chemotherapy/radiotherapy. Patients who have undergone a hysterectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the diagnostic accuracy of CerviAI-Assisted detection of biopsy proven high-grade squamous abnormalities of the cervix (HSIL, ASC-H) as compared to manually reported LBC smearsTimepoint: Index (CerviAI) and comparator (manual LBC) will be performed on the same LBC specimen at Day 0. Colposcopy and biopsy must occur within 50 days of sampling for positive cases | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of CerviAI in detecting low-grade squamous intraepithelial lesions (LSIL) and atypical squamous cells of undetermined significance (ASCUS), compared to manual LBC reporting.Timepoint: Assessed at the time of initial cervical screening and correlated with follow-up biopsy or repeat cytology/HPV triage during the 12-month study period. | — |
Countries
India
Contacts
Public ContactDr Sashmita Swain
Vyuhaa Med Data Private Limited
Outcome results
None listed