Clinical trial NCT04480866: CASUS: Improved and Quality Assured Collection of First-void Urine
Official title: Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma
Urine
Keywords: Biomarker
First-void urine
Screening
Triage
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Novosanis NV
name: Self-screen B.V.
First posted: 2020-07-21
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Human DNA (GAPDH)
timeFrame: Evaluation/testing when all samples are collected [1 year]
measure: Internal control DNA (IC DNA)
timeFrame: Evaluation/testing when all samples are collected [1 year]
measure: Human DNA reference gene (ACTB)
timeFrame: Evaluation/testing when all samples are collected [1 year]
Secondary outcomes:
measure: Human DNA (Beta-globin)
timeFrame: Evaluation/testing when all samples are collected [1 year]
measure: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68))
timeFrame: Evaluation/testing when all samples are collected [1 year]
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp
state: Antwerpen
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Alex Vorsters, Ir, PhD
role: STUDY_CHAIR
affiliation: Universiteit Antwerpen
name: Severien Van Keer, PhD
role: STUDY_CHAIR
affiliation: Universiteit Antwerpen
name: Laura Téblick, Ir
role: STUDY_CHAIR
References: