None listed
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Tata Memorial Hospital Intramural funds
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women in age group of 30-65 years. 2. Married or sexually active women. 3. Women having undergone subtotal hysterectomy with intact cervix in the age group of 30-65 years. 4. Screened positive lesion on VIA as a primary screening test. 5. Women with a significant acetowhite lesion on colposcopy with screen positive on HPVDNA as a primary screening test. 6. Women with cervical growth on per speculum examination. 7. Women with suspicious erosion on VIA screening test or colposcopy.
Exclusion criteria
Exclusion criteria: 1. Women having past history of treatment for precancerous or cancerous lesions. 2. Women with total hysterectomy. 3. Women who have undergone cervical cancer screening within 2 years and have a negative screening test report.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quantification of p16 INK4A protein levels in healthy cervical samples. 2. Quantification of p16 INK4A protein levels in precancerous lesions and determination of fold dif- ference as compared to the healthy samples. 3. Standardization set for the proposed p16 LaF under development.Timepoint: Quarterly for 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Attitude and perception towards cervical cancer screening in community. 2. Prevalence of oncogenic HPV type 16, type 18 and other High-risk types in the community. 3. Prevalence of oncogenic HPV type 16, type 18 and other High-risk types in precancerous and can- cerous lesion positive for p16. 4. Prevalence of p16 in VIA negative women (understand the false positives) on Pap smear. 5. Prevalence of p16 levels in abnormal Pap smears collected as a triage test for women positive on VIA 6. Concordance between HPVDNA-PCR testing, Pap smears and P16 levels in benign, precancerous and cancerous lesions. 7. Prevalence of p16 levels in squamous metaplasia. 8. Correlation of P16 levels in squamous metaplasia to Pap test, HPVDNA test and Swede score on colposcopy.Timepoint: Quarterly for 2 years | — |
Countries
India
Contacts
Public ContactDr Gauravi Mishra
Tata Memorial Hospital
Outcome results
None listed