Comparing the value of HPV transcript analysis and analysis of DNA methylation status for stratification of high-risk HPV positive women for risk of developing high grade cervical intraepithelial neoplasia (CIN) lesions and cervical carcinoma, to that of conventional cytology.

Comparing the value of HPV transcript analysis and analysis of DNA methylation status for stratification of high-risk HPV positive women for risk of developing high grade cervical intraepithelial neoplasia (CIN) lesions and cervical carcinoma, to that of conventional cytology. - Comparing methods for stratification of high-risk HPV positive women

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37087

Enrollment

300

Registered

2009-09-02

Start date

2010-12-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

cervical cancer cervical intraepithelial neoplasma

Interventions

At intake, a cervical smear sample is collected and will be tested for the presence of hr-HPV DNA. Subsequently, only in women who are hr-HPV DNA positive, (reflex) cytology is examined. Hr-HPV posi

i.e. HPV DNA positive women with pap 1, will undergo followed-up cytology, hr-HPV DNA- testing and subsequently colposcopy at six months. In case no lesions are visible, a blind biopsy will be taken

i.e. Women with a positive hr-HPV DNA test but negative mRNA test at baseline (group C) will be followed-up at 6 months by repeat smears for cytology, hr-HPV DNA-and hr-HPV mRNA testing and subseque

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women between 20-70 years of age Cervical smear is high-risk HPV DNA positive cervix intact (no history of surgical treatment involving damage to transformation zone of cervix)

Exclusion criteria

Exclusion criteria: Women unable to take a vaginal self-sample Cervical smear is hr-HPV DNA negative (previous) abnormal cervical smear of at least BMD (pap3a2) or cervical cancer within preceding 2 years presents of any cancer but cervical cancer history of surgery on cervix Pregnancy or having been pregnant (equally for breast-feeding) in the last 3 months heavy vaginal bleeding

Design outcomes

Primary

Measure	Time frame
Endpoint is histology outcome; i.e. presence or absence of CIN2 lesions. The short-term risk of CIN2 will be assessed as a function of E7 transcript and DNA methylation status. The sensitivity, specificity, positive and negative predictive values of mRNA testing and analysis of DNA promoter methylation for detection of *CIN2 lesions in hr-HPV positive women will be determined and compared to that of cytology.	—

Measure

Time frame

Endpoint is histology outcome; i.e. presence or absence of *CIN2 lesions. The short-term risk of *CIN2 will be assessed as a function of E7 transcript and DNA methylation status. The sensitivity, specificity, positive and negative predictive values of mRNA testing and analysis of DNA promoter methylation for detection of *CIN2 lesions in hr-HPV positive women will be determined and compared to that of cytology.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)