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CASUS: Validation for Detection of Precursor Lesions (CASUS-WP4)

Primary Purpose

Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Colli-Pee Small Volumes (10 mL) device
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring Biomarker, First-void urine, Screening, Triage

Eligibility Criteria

25 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)
  • Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen
  • Gynécologie-obstétrique - CHU de Liège

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sample collection

Arm Description

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.

Outcomes

Primary Outcome Measures

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+].
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+].

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2020
Last Updated
June 14, 2022
Sponsor
Universiteit Antwerpen
Collaborators
Amsterdam UMC, location VUmc, Novosanis NV, Self-screen B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04530201
Brief Title
CASUS: Validation for Detection of Precursor Lesions
Acronym
CASUS-WP4
Official Title
Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Validation for Detection of Precursor Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Amsterdam UMC, location VUmc, Novosanis NV, Self-screen B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma, Urine
Keywords
Biomarker, First-void urine, Screening, Triage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sample collection
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Colli-Pee Small Volumes (10 mL) device
Intervention Description
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 Outcome Measure Information:
Title
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).
Description
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+].
Time Frame
Through study completion, an average of 1 year
Title
Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP).
Description
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+].
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Human DNA (GAPDH)
Description
Human DNA (GAPDH) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).
Time Frame
Through study completion, an average of 1 year
Title
Internal control DNA (IC DNA)
Description
Internal control DNA (IC DNA) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).
Time Frame
Through study completion, an average of 1 year
Title
Human DNA (Beta-globin)
Description
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).
Time Frame
Through study completion, an average of 1 year
Title
Human DNA reference gene (ACTB)
Description
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).
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Van Damme, MD, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Vorsters, Ir, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Severien Van Keer, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
Facility Information:
Facility Name
Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen
City
Tienen
State/Province
Vlaams-Brabant
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Gynécologie-obstétrique - CHU de Liège
City
Liège
ZIP/Postal Code
4030
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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CASUS: Validation for Detection of Precursor Lesions

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