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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2022 |
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Main ID: |
NCT03542513 |
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Date of registration:
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18/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
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Scientific title:
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Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN) |
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Date of first enrolment:
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October 30, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03542513 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Pierre Van Damme |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre for the Evaluation of Vaccination |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female (18 years and older)
- Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN
lesions
- Giving informed consent to the research team (CEV) to contact his/her GP and/or
gynaecologist to access details of the participants HPV vaccination (schedule) and
results of cervical smears/cytology, HPV tests, colposcopy, and biopsy.
- Not participating in another clinical study where a drug or biological is
administered.
- Able to understand the information brochure/what the study is about.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical Cancer
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Intervention(s)
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Device: Qvintip
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Device: Colli-Pee
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Primary Outcome(s)
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hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
[Time Frame: Within 6 months after study completion]
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Secondary Outcome(s)
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hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.
[Time Frame: Within 6 months after study completion]
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Effect of treatment on HPV DNA presence.
[Time Frame: Within 6 months after study completion]
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Validate the performance of additional biomarkers.
[Time Frame: Within 6 months after study completion]
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Preference of women for self-sampling methods.
[Time Frame: Within 6 months after study completion]
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Secondary ID(s)
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B300201732818
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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