CASUS: Validation for Detection of Precursor Lesions

NCT04530201 | Completed

• 1 other identifier: BE3002020000101
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 3

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 (2)

• 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).

  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 \[Cervical Intraepithelial Neoplasia grade 0-3+\].

  Through study completion, an average of 1 year

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

  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 \[Cervical Intraepithelial Neoplasia grade 0-3+\].

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Human DNA (GAPDH)

  Through study completion, an average of 1 year

• Internal control DNA (IC DNA)

  Through study completion, an average of 1 year

• Human DNA (Beta-globin)

  Through study completion, an average of 1 year

• Human DNA reference gene (ACTB)

  Through study completion, an average of 1 year

Study Arms (1)

Sample collection

OTHER

Women will self-collect two first-void urine samples at home, the day prior to colposcopy. During the colposcopy visit, the clinician will collect an additional cervical smear. Colposcopy and histology results (when available) will be used as reference test.

Device: Colli-Pee Small Volumes (10 mL) device

Interventions

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.

Sample collection

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

Location

Gynécologie-obstétrique - CHU de Liège

Liège, 4030, Belgium

Location

Related Publications (1)

• Hendrickx JO, Van Keer S, Donders G, Weyers S, Doyen J, Beyers KCL, Rios-Cortes A, Meers N, Teblick L, Vankerckhoven VVJ. Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study. Arch Public Health. 2025 Feb 12;83(1):32. doi: 10.1186/s13690-024-01490-3.

  PMID: 39934916 DERIVED

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

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: August 24, 2020
• First Posted: August 28, 2020
• Study Start: August 20, 2020
• Primary Completion: October 20, 2021
• Study Completion: February 28, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)