Uterine Cervical NeoplasmCOMBISCREENNCT06598176
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
A study testing Colli-Pee 20mL device with UCM and Evalyn Brush in people with Uterine Cervical Neoplasm and Uterine Cervical Dysplasia, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasm, Uterine Cervical Dysplasia, Human Papilloma Virus
- What is being tested?
- Colli-Pee 20mL device with UCM and Evalyn Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Mar 2024to 28 Feb 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- 25 until 64 years old
- Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)
- Has not started any form of cancer treatment prior to study enrollment
- Written informed consent must be obtained from patient
- Is able to understand the information brochure and what the study is about
Who cannot join
- Women that underwent hysterectomy
- Pregnant women or 6 weeks post-partum
- Treatment for cervical (pre)cancer in the last 6 months before participation in the study
- 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.
- Unable to give informed consent
- Patient has severe anaemia
Show all 11Show fewer
- Patient received blood transfusion two weeks before sample collection
- Blood sampling would compromise patients' overall health
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Patients who are alcoholic or drug abusers
- Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, 2650
Wiebren Tjalma, MD, PhD, 038213250 ext. +32, wiebren.tjalma@uza.be
About this study
Official title: Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)
The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.
Read the detailed description
Currently, there is still 37% of the Flemish population eligible for cervical cancer screening that remains un(der)screened. Self-collected urine and vaginal samples that can be collected from home and are non-invasive provide an attractive alternative for this group. The aim of this study is to collect different samples from patients with a cervical cancer or a scheduled conization in order to identify potential biomarkers for cervical cancer and cervical intraepithelial neoplasia (CIN). These samples include a home-collected first-void urine (Colli-Pee 20mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn Brush), as well as a clinician collected cervical smear, blood sample and when appropriate also a tissue sample. A tissue sample will only be collected when the patient is undergoing surgical procedures for their standard therapy. As such, they do not undergo additional invasive procedures as part of the study. The samples are collected prior to starting therapeutic processes (e.g. conization, chemotherapy, radiotherapy, surgery…). The presence of biomarkers (e.g. human papillomavirus (HPV) and DNA methylation) for cervical cancer and cervical intraepithelial neoplasia (CIN) will be determined and compared in each of the sample types. The results of the biomarker assays will also be compared to clinical results from cytology and histology in order to determine the accuracy.
- Conditions
- Uterine Cervical Neoplasm, Uterine Cervical Dysplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma
- Being tested
- Colli-Pee 20mL device with UCM, Evalyn Brush
- Keywords
- biomarker, first-void urine, vaginal sample, screening, triage, self-sampling, prevention
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colli-Pee 20mL device with UCMDevice
Women will collect a first-void urine (the initial part of the urine stream) sample at home the day before a hospital appointment using the 20mL Colli-Pee device prefilled with urine conservation medium (UCM, Novosanis, Belgium).
Evalyn BrushDevice
Women will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment.
| Study group | Role | What they receive |
|---|---|---|
| Sample collection | Experimental | Women will collect one first-void urine sample and one vaginal self-sample at home, one day prior to a scheduled appointment at the hospital. During the hospital visit, an additional clinician collected cervical smear and a blood sample will be collected for the study. In case, the patient also undergoes a surgical intervention for their standard treatment plan, the tissue that is collected there, will also be used and analysed for our study. Cytology and histology results will be used as reference test. Receives: Device: Colli-Pee 20mL device with UCM; Device: Evalyn Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of (epi)genetic biomarkers for cervical cancer and precancer
A novel assay will be developed for the detection of the human papillomavirus (HPV) and epigenetic biomarkers to determine the presence of cervical (pre)cancer. Using histology outcomes as a reference test.
Measured: 48 months
Secondary outcomes (3)
Comparison of the biomarkers detected in the different sample types.
The biomarkers detected in each of the sample types and their performance will be compared.
Measured: 48 months
Demonstrate non-inferiority of the biomarker assay in self-samples compared to conventional cytology on pap smears.
Demonstrate non-inferiority of the developed biomarker assay in self-samples (index tests) compared to conventional cytology on pap smears (comparator test) for the detection of cervical (pre)cancer, using histology outcomes from tissue samples as reference test.
Measured: 48 months
Determine the predictive value of the biomarker assay and the long-term risk of cervical (pre)cancer
Determine the developed biomarker assay's predictive value and long-term risk of cervical (pre)cancer after an initial test-outcome. Measuring the cumulative incidence of cervical (pre)cancer over time. Using histology outcomes from tissue samples ten years pre- and post-study enrolment as reference test outcomes.
Measured: Within 1 year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Mar 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Wiebren Tjalma, Universiteit Antwerpen
- Investigators
- Wiebren Tjalma, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598176
- Sponsor's protocol ID
- B3002023000030
- Acronym
- COMBISCREEN
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)
- ClinicalTrials.gov ID
- NCT06598176
- Acronym / sponsor ID
- COMBISCREEN / B3002023000030
- Conditions
- Uterine Cervical Neoplasm, Uterine Cervical Dysplasia, Human Papilloma Virus, HPV-Related Cervical Carcinoma
- Keywords
- biomarker, first-void urine, vaginal sample, screening, triage, self-sampling, prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2037 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.
Detailed description
Currently, there is still 37% of the Flemish population eligible for cervical cancer screening that remains un(der)screened. Self-collected urine and vaginal samples that can be collected from home and are non-invasive provide an attractive alternative for this group. The aim of this study is to collect different samples from patients with a cervical cancer or a scheduled conization in order to identify potential biomarkers for cervical cancer and cervical intraepithelial neoplasia (CIN). These samples include a home-collected first-void urine (Colli-Pee 20mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn Brush), as well as a clinician collected cervical smear, blood sample and when appropriate also a tissue sample. A tissue sample will only be collected when the patient is undergoing surgical procedures for their standard therapy. As such, they do not undergo additional invasive procedures as part of the study. The samples are collected prior to starting therapeutic processes (e.g. conization, chemotherapy, radiotherapy, surgery…). The presence of biomarkers (e.g. human papillomavirus (HPV) and DNA methylation) for cervical cancer and cervical intraepithelial neoplasia (CIN) will be determined and compared in each of the sample types. The results of the biomarker assays will also be compared to clinical results from cytology and histology in order to determine the accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collection | Experimental | Device: Colli-Pee 20mL device with UCM, Device: Evalyn BrushWomen will collect one first-void urine sample and one vaginal self-sample at home, one day prior to a scheduled appointment at the hospital. During the hospital visit, an additional clinician collected cervical smear and a blood sample will be collected for the study. In case, the patient also undergoes a surgical intervention for their standard treatment plan, the tissue that is collected there, will also be used and analysed for our study. Cytology and histology results will be used as reference test. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- 25 until 64 years old
- Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)
- Has not started any form of cancer treatment prior to study enrollment
- Written informed consent must be obtained from patient
Key exclusion criteria (11 listed)
- Women that underwent hysterectomy
- Pregnant women or 6 weeks post-partum
- Treatment for cervical (pre)cancer in the last 6 months before participation in the study
- 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.
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colli-Pee 20mL device with UCMWomen will collect a first-void urine (the initial part of the urine stream) sample at home the day before a hospital appointment using the 20mL Colli-Pee device prefilled with urine conservation medium (UCM, Novosanis, Belgium). | Device | Sample collection |
| Evalyn BrushWomen will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment. | Device | Sample collection |
Primary outcome
Detection of (epi)genetic biomarkers for cervical cancer and precancer
Time frame: 48 months
A novel assay will be developed for the detection of the human papillomavirus (HPV) and epigenetic biomarkers to determine the presence of cervical (pre)cancer. Using histology outcomes as a reference test.
3 secondary outcomes
Comparison of the biomarkers detected in the different sample types.
Time frame: 48 months
Demonstrate non-inferiority of the biomarker assay in self-samples compared to conventional cytology on pap smears.
Time frame: 48 months
Determine the predictive value of the biomarker assay and the long-term risk of cervical (pre)cancer
Time frame: Within 1 year after study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wiebren Tjalma, MD, PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colli-Pee 20mL device with UCM and Evalyn Brush in people with Uterine Cervical Neoplasm and Uterine Cervical Dysplasia, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Vorsters, Ir, PhD (032659130 ext. +32, alex.vorsters@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of (epi)genetic biomarkers for cervical cancer and precancer (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.