high risk HPV detection from urine and self-collected specimens as patient friendly alternative for physician taken smears

high risk HPV detection from urine and self-collected specimens as patient friendly alternative for physician taken smears - HPV detection and stability from urine and self-collected specimens

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48967

Enrollment

Registered

2018-07-09

Start date

2019-01-25

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Cervical dysplasia / Cervical cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: HPV positive woman 18 years or older

Exclusion criteria

Exclusion criteria: Pregnant Under 18 years of age

Design outcomes

Primary

Measure	Time frame
For both the self-collected specimens and urine the most optimal combination of HPV DNA/RNA isolation and detection will be determined. Stability of HPV DNA and RNA on the Evalyn Brush will be investigated by comparing results on timepoints T=0 and T=4 days. For urine, the effect of adding preservationmedium on stability of HPV DNA and RNA will be investigated. Furthermore, urine will be analysed on different timepoints (T=0, 4 and 7 days) to analyse stability of HPV. All obtained results from the self-collected specimens and urine will be compared to the results of the physician taken smear (routine diagnostics, golden standard).	—

Measure

Time frame

For both the self-collected specimens and urine the most optimal combination of HPV DNA/RNA isolation and detection will be determined. Stability of HPV DNA and RNA on the Evalyn Brush will be investigated by comparing results on timepoints T=0 and T=4 days. For urine, the effect of adding preservationmedium on stability of HPV DNA and RNA will be investigated. Furthermore, urine will be analysed on different timepoints (T=0, 4 and 7 days) to analyse stability of HPV. All obtained results from the self-collected specimens and urine will be compared to the results of the physician taken smear (routine diagnostics, golden standard).

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results