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

NCT04480866 | Completed

• 1 other identifier: B300201940120
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Biomarker; First-void urine; Screening; Triage

Outcome Measures

Primary Outcomes (3)

• Human DNA (GAPDH)

  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)

  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)

  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 Outcomes (2)

• Human DNA (Beta-globin)

  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))

  Evaluation/testing when all samples are collected [1 year]

Study Arms (1)

First-void urine collection

OTHER

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

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

Interventions

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.

First-void urine collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Amsterdam UMC, location VUmc: collaborator
• Novosanis NV: collaborator
• Self-screen B.V.: collaborator

Study Sites (1)

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

Wilrijk, Antwerpen, 2610, Belgium

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Pierre Van Damme, MD, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Alex Vorsters, Ir, PhD

  Universiteit Antwerpen

  STUDY CHAIR

• Severien Van Keer, PhD

  Universiteit Antwerpen

  STUDY CHAIR

• Laura Téblick, Ir

  Universiteit Antwerpen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: July 21, 2020
• Study Start: July 30, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 27, 2019
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)