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

U

Universiteit Antwerpen

Status

Completed

Conditions

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

Treatments

Device: Colli-Pee® (FV5000 and Small Volumes)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04480866
B300201940120

Details and patient eligibility

About

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).

Full 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.

Enrollment

25 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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