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NCT Number: NCT04480866

CASUS: 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).

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Key information

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV-Related Cervical Carcinoma Human Papilloma Virus Neoplasms Neoplasms by Site Precancerous Conditions Urine Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Wilrijk, Antwerpen, 2610, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colli-Pee® (FV5000 and Small Volumes)

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CASUS-WP1

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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