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Discovery of biomarkers in cervical smears for diagnosis and prognosis of cervical lesions

Discovery of biomarkers in cervical smears for diagnosis and prognosis of cervical lesions - PRECARE-RNA profiling of cervical smears

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51329
Enrollment
570
Registered
2023-02-08
Start date
2024-01-05
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

CIN leasions premalignancy of cervical cancer

Interventions

Cervical cytology, vaginal swab and/or biopsy

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age>=18 years - Signed informed consent - Women did notno opt-out for making their smear available for research - Women who undergo a colposcopy examination because of a positive HPV test and an abnormal PAP-smear. - Women in follow up after a radical vaginal trachelectomy - Women diagnosed with cervical cancer

Exclusion criteria

Exclusion criteria: - Women who are pregnant during the colposcopy or surgery - Women who are not able to understand the study-information - Women whom did not signed informed consent.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the difference in gene-expression profiles between cervical smears from healthy women and women with CIN1, CIN2, CIN3 and cancer lesions

Secondary

MeasureTime frame
The second objective is to evaluate how gene expression profiles in smears relate to gene expression profiles in matching dysplastic or cancer tissue.

Countries

Netherlands

Contacts

Public ContactP.L.M Zusterzeel

Radboud Universitair Medisch Centrum

petra.zusterzeel@radboudumc.nl024-3611111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)