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Evaluating the Visual Appearance of Cervical Lesions in Relation its Histological Diagnosis, Human Papillomavirus Genotype and Other Viral Parameters: a Prospective Cohort Study

Evaluating the Visual Appearance of Cervical Lesions in Relation its Histological Diagnosis, Human Papillomavirus Genotype and Other Viral Parameters: a Prospective Cohort Study - EVAH study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41350
Enrollment
100
Registered
2010-05-18
Start date
2010-07-29
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 Intraepithelial Neoplasia Cervical lesions

Interventions

None listed

Sponsors

DDL Diagnostic Laboratory
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -An abnormal cytological test result -18 years of age or older -Written informed consent prior to enrolment -Sufficient knowledge of the Dutch language -The intention to comply with the requirements of the protocol

Exclusion criteria

Exclusion criteria: -History of surgery on the cervix -Previous pelvic radiotherapy -Pregnancy or pregnant in the last 3 months -Actually breast-feeding or breast-feeding in the last 3 months -Diagnosis of cervix carcinoma

Design outcomes

Primary

MeasureTime frame
Primary study parameters are: - Digitalized colposcopic imaging results - Histological examination data (CIN classification of lesions) - HPV results from LCM isolated lesions - HPV results from entire LEEP/ biopsies

Secondary

MeasureTime frame
Secondary study parameters are: - HPV results from cervico-vaginal self samples - HPV results from physician-taken cervical scrapes

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)