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

NCT ID: NCT04480866

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2019-11-27

Brief Summary

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).

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.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma; Urine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

First-void urine collection

Women self-collect three first-void urine samples (random order) at home.

Group Type: OTHER

Colli-Pee® (FV5000 and Small Volumes)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Novosanis NV

INDUSTRY

Sponsor Role: collaborator

Self-screen B.V.

UNKNOWN

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Pierre Van Damme

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre Van Damme, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Alex Vorsters, Ir, PhD

Role: STUDY_CHAIR

Universiteit Antwerpen

Severien Van Keer, PhD

Role: STUDY_CHAIR

Universiteit Antwerpen

Laura Téblick, Ir

Role: STUDY_CHAIR

Universiteit Antwerpen

Locations

Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp

Wilrijk, Antwerpen, Belgium

Countries

Belgium

Other Identifiers

B300201940120

Identifier Type: -

Identifier Source: org_study_id