Skip to main content
OpenTrials
Completed

NCT Number: NCT04530201

CASUS: Validation for Detection of Precursor Lesions

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).

Completed

Looking for future studies?

Notify Me

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

25 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent), Ghent, Oost-Vlaanderen, Belgium

Loading trial locations.

About this study

CASUS work package 4 (WP4):

The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands) followed by multiplex methylation specific quantitative PCR (qMSP, VU University Medical Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device, Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor lesions by sampling a cohort of women referred for colposcopy. The number of women in this cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA extracts of first-void samples after optimization of sample volume, internal process control, and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp, Belgium).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female
  • 25 years until 64 years old
  • Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion.
  • Gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
  • Is able to understand the information brochure/what the study is about.

Exclusion criteria

  • Women that underwent hysterectomy
  • Pregnant women
  • Treatment for cervical cancer in the last 6 months before participation in the study
  • Participating in an 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 Small Volumes (10 mL) device

Device

Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.

Primary outcomes

  1. HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).

    Time frame: Through study completion, an average of 1 year

    Analytical test results:

    HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) concentrations [cycle threshold values] in first-void urine samples from all study participants.

    Clinical test accuracy:

    HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) test outcomes [positive, negative] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology [Cervical Intraepithelial Neoplasia grade 0-3+].

  2. Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP).

    Time frame: Through study completion, an average of 1 year

    Analytical test results:

    Methylation levels of a host cell gene marker panel (PreCursor-U+) reported in a methylation ratio [(2^-deltaCT *100) with CT being cycle threshold values] in first-void urine samples from all study participants.

    Clinical test accuracy:

    Methylation panel (PreCursor-U+) test outcomes [positive, negative] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology [Cervical Intraepithelial Neoplasia grade 0-3+].

Secondary outcomes

  1. Human DNA (GAPDH)

    Time frame: Through study completion, an average of 1 year

    Human DNA (GAPDH) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).

  2. Internal control DNA (IC DNA)

    Time frame: Through study completion, an average of 1 year

    Internal control DNA (IC DNA) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).

  3. Human DNA (Beta-globin)

    Time frame: Through study completion, an average of 1 year

    Human DNA (Beta-globin) concentrations [cycle threshold values] in first-void urine samples from all study participants measured using the HPV-risk assay (Self-Screen BV).

  4. Human DNA reference gene (ACTB)

    Time frame: Through study completion, an average of 1 year

    Human DNA reference gene (ACTB) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative methylation specific PCR (qMSP).

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: Validation for Detection of Precursor Lesions

Acronym: CASUS-WP4

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 28, 2020
Registry last updated
Jun 15, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.