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Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)

NCT02714127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2017-06-15

No results posted yet for this study

Summary

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions.

Conditions

Interventions

OTHER

First-void urine collection

One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).

OTHER

Cervicovaginal lavage fluid collection

During colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • University Hospital, Antwerp

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Pierre Van Damme, Prof MD PhD · Universiteit Antwerpen

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714127 on ClinicalTrials.gov