CASUS: Improved and Quality Assured Collection of First-void Urine (CASUS-WP1)

July 17, 2020 updated by: Pierre Van Damme, Universiteit Antwerpen

Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine

The goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void urine, a next-generation first-void urine collection device is necessary, which includes internal process control, novel collector tubes for collection of smaller urine volumes, and integration of a non-toxic nucleic acid preservative.

Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard' Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The optimal urine volume needed for detection of host and viral biomarkers, as well as optimization of the nucleic acid preservative solution by introduction of a sample/extraction validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using different DNA extraction protocols.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • 18 years and older
  • Women with a high-risk HPV positive test result within six months prior to study enrolment.
  • Giving informed consent to the research team to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
  • Able to understand the information brochure/what the study is about.

Exclusion Criteria:

  • Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
  • Participating in another interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: First-void urine collection
Women self-collect three first-void urine samples (random order) at home.
Device: Colli-Pee® (FV5000 and Small Volumes)

Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL.

Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human DNA (GAPDH)
Time Frame: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA (GAPDH) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Evaluation/testing when all samples are collected [1 year]
Internal control DNA (IC DNA)
Time Frame: Evaluation/testing when all samples are collected [1 year]
Comparison of internal control DNA (IC DNA) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
Evaluation/testing when all samples are collected [1 year]
Human DNA reference gene (ACTB)
Time Frame: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA reference gene (ACTB) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative methylation specific PCR (qMSP).
Evaluation/testing when all samples are collected [1 year]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human DNA (Beta-globin)
Time Frame: Evaluation/testing when all samples are collected [1 year]
Comparison of human DNA (Beta-globin) concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
Evaluation/testing when all samples are collected [1 year]
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))
Time Frame: Evaluation/testing when all samples are collected [1 year]
Comparison of HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) positivity (+/-) and concentrations [cycle threshold values] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured using the HPV-risk assay (Self-Screen BV).
Evaluation/testing when all samples are collected [1 year]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

Amsterdam UMC, location VUmc
Novosanis NV
Self-screen B.V.

Investigators

  • Study Chair: Laura Téblick, Ir, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Actual)

November 25, 2019

Study Completion (Actual)

November 27, 2019

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201940120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on Colli-Pee® (FV5000 and Small Volumes)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe