Skip to content

P16/Ki67 cytology staining for detection of cervical high grade intraepithelial lesion in woman with positive high-risk types of Human Papilloma Virus with normal cytology

P16/Ki67 cytology staining for detection of CIN 2+ lesion in woman with positive high-risk types of Human Papilloma Virus with normal cytology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20250808002
Enrollment
94
Registered
2025-08-08
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

CIN2+ lesion in woman positive with positive high-risk HPV infection with normal cervical cytologic result Cervical cancer screening, Cytology, HPV testing, Dual staining

Interventions

Woman with positive high-risk HPV with normal cervical cytology (NILM)
Diagnostic
Woman with positive high-risk HPV with normal cytology

Sponsors

Faculty of Medicine, Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Women aged 25-65 years who receive examination at the Gynecology Outpatient Department, Princess Maha Chakri Sirindhorn Medical Center, Faculty of Medicine, Srinakharinwirot University. 2) Detected of high-risk HPV strains with normal cytology results (NILM). 3) Have no history of CIN 2+ lesions or previous treatment. 4) Consent to participate in the research and have received informed consent.

Exclusion criteria

Exclusion criteria: 1) Pregnancy 2) Repeat cytology test results are abnormal 3) History of CIN 2+ lesions detected or treated 4) Refusal to undergo a cervical dilation or unable to attend a follow-up examination

Design outcomes

Primary

MeasureTime frame
Detection rate for CIN2+ lesion at point when Dual staining was done Dual staining(p16/Ki-67) of cervical liquid-base cytology compared to pathologic result from colposcopic biopsy

Secondary

MeasureTime frame
HPV type related to positive result of dual staining test at point when Dual staining was done Data from Paticipant's specimen

Countries

Thailand

Contacts

Public ContactWarat Duangpirom

Faculty of Medicine, Srinakharinwirot University

prompt095@gmail.com0831347724

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026