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A study to compare the detection rate of E6/E7 gene in cervical samples of females with HPV infections, with their cervical biopsy results.

Comparison of PCR based E6/E7 Oncogene detection in cervical cytology and cervical tissue specimen with histopathology in HPV-positive women - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072693
Enrollment
100
Registered
2024-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: E6/E7 Oncogene detection in cervical cytology and cervical tissue specimen in HPV-positive women: E6/E7 oncogene test results will be analyzed in relation to the HPV DNA positivity and

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women aged = 30 – 65 years 2. No previous history of cervical lesions or cervical cancer 3. Willing to participate in the study after informed written consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Inadequate cervical cytology/tissue sample 3. Active PID, genital infection, vaginal discharge 4. Previously treated for preinvasive or invasive lesions of cervix

Design outcomes

Primary

MeasureTime frame
1. Compare the PCR based E6/E7 oncogene testing in cervical cytology to the histopathological diagnosis in HPV positive samples. 2. Compare the PCR based E6/E7 oncogene testing in cervical tissue to the histopathological diagnosis in HPV positive samples. Timepoint: 1. After getting test results 2. At the end of the study, by June 2026—

Secondary

MeasureTime frame
1. Compare E6 & E7 oncogene detection in cervical cytology & tissue samples with final histopathology results 2. Compare the E6/E7 oncogene detection rates in cervical cytology with HPV positivity 3. Compare the E6/E7 oncogene detection rates in cervical tissue with HPV positivity Timepoint: 1. After getting test results 2. At the end of the study, by June 2026—

Countries

India

Contacts

Public ContactDr Jyoti Meena

AIIMS, New Delhi

drjyotirajesh@gmail.com9953937130

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026