Human Papillomavirus InfectionURINORMNCT06582654
Normalizing Antibody Detection in First-void Urine
An observational study of Human Papillomavirus Infection, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts. Read more about this study
- Who is it for?
- Ages 9 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Sampling
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Dec 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 9 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 150 participants will be included, consisting of six different cohorts, including a group of pre-adolescent girls (n=25), a group of young women using ovulation-influencing contraceptives (n=25), a group of young women using non-ovulation-influencing contraceptives (n=25), a group of young women using no contraceptives (n=25), a group of post-menopausal women (n=25), and a group of men (n=25).
Who may be able to join
- Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this.
- Able to understand the information brochure and what the study is about.
- Willing to give informed consent to contact his/her general practitioner and/or gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).
Who cannot join
- Participating in another clinical trial at the same time of participating in this study.
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment.
- Pregnant women.
- Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Having 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 individual to participate, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp
Edegem, Antwerp, 2650
Alex Vorsters, Professor, +3232659130, alex.vorsters@uantwerpen.be
Margo Bell, +32476014843, margo.bell@uantwerpen.be
About this study
Official title: URINORM: Normalizing Antibody Detection in First-void Urine
The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.
Read the detailed description
To date, invasive clinician-collected cervical samples, blood, and vaginal samples are still the primary methods to monitor disease and immune responses to vaccine-preventable genital tract infections. Replacing these samples with a specimen that is non-invasive and can be self-collected at home could have important acceptance and feasibility advantages and could facilitate the logistics of clinical trials and future epidemiological studies. Initial results of experiments using first-void urine samples for immune response monitoring are promising. However, overall standardization and normalization of fluctuation in signals are necessary for it to become a suitable genital tract liquid biopsy in vaccine research. Therefore, the aim of this study is to normalize antibody detection in first-void urine by reducing sample variability, using the human papillomavirus (HPV) as a model.
A total of 150 participants will be included, consisting of six different cohorts, including a group of pre-adolescent girls (n=25), a group of young women using ovulation-influencing contraceptives (n=25), a group of young women using non-ovulation-influencing contraceptives (n=25), a group of young women using no contraceptives (n=25), a group of post-menopausal women (n=25), and a group of men (n=25). Participants will be followed over a period of 36 days, and will be asked to self-collect 6 to 21 first-void urine samples (depending on cohort) using a Colli-Pee 20mL (Novosanis). Moreover, participants will have two scheduled visits (day 1 and 36 of the study) at the study site, where each time a blood collection (1x 5-10cc) will be performed.
Collected first-void urine and serum samples will be analyzed for menstrual cycle-related fluctuations and between-group differences in HPV-specific antibody levels. Moreover, to compare immunological with viral endpoints, HPV DNA detection and genotyping will be performed on the first-void urine sample and samples will be tested for various biomarkers that might be valuable for the normalization of inter- and intra-individual variability.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Sampling
- Keywords
- Antibodies, Vaccination, Self-sampling, First-void urine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingDevice
Collection of first-void urine (i.e. the initial stream of the urine) with the Colli-Pee device (Novosanis, Belgium) (6-21 samples over a period of 36 days).
Collection of blood samples (2 samples, at day 1 and 36 of the study).
| Study group | Role | What they receive |
|---|---|---|
| Pre-adolescent group | Defined as girls between 9 and 14 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not yet menstruating (pre-menarche). Receives: Device: Sampling | |
| Ovulatory group | Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not using any hormone- or ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle. Receives: Device: Sampling | |
| Ovulation-influencing contraceptive group | Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle (including oral contraceptives, hormonal ring, contraceptive injection, contraceptive patch, hormonal implant). Receives: Device: Sampling | |
| Non-ovulation-influencing contraceptive group | Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using contraceptives that do not affect ovulation (i.e. intrauterine devices). Receives: Device: Sampling | |
| Post-menopausal group | Defined as fully vaccinated women between 50 and 70 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and have had no menses for at least one year. Receives: Device: Sampling | |
| Male group | Defined as fully vaccinated men between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine. Receives: Device: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of total and HPV-specific IgG (immunoglobulin G) in first-void urine.
To follow-up levels of total and HPV-specific antibodies in first-void urine at repeated measurements and compare levels of total and HPV-specific antibodies in first-void urine between young men, pre-adolescent girls, post-menopausal women, and women on a contraceptive or ovulatory cycle.
Measured: Within six months after completion of the study
Secondary outcomes (3)
Concentration of total and HPV-specific IgG (immunoglobulin G) in serum.
To compare levels of total and HPV-specific antibodies in serum at repeated measurements and look into correlation between total and HPV-specific antibodies in serum and first-void urine.
Measured: Within six months after completion of the study
HPV DNA status of first-void urine samples.
To test for the presence of HPV DNA in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV.
Measured: Within six months after completion of the study
Other biomarkers/analyses.
To test various biomarkers (e.g. total IgG, IgG subclasses, total protein, total human DNA…) in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV and perform other relevant analyses within the scope of the study.
To test various biomarkers (e.g. total IgG, IgG subclasses, total protein, total human DNA…) in first-void urine samples from different cohorts of men, girls and women vaccinated against HPV and perform other relevant analyses within the scope of the study.
Measured: Within six months after completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start7 Dec 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582654
- Sponsor's protocol ID
- B3002023000105
- Acronym
- URINORM
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 3 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- URINORM: Normalizing Antibody Detection in First-void Urine
- ClinicalTrials.gov ID
- NCT06582654
- Acronym / sponsor ID
- URINORM / B3002023000105
- Conditions
- Human Papillomavirus Infection
- Keywords
- Antibodies, Vaccination, Self-sampling, First-void urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 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 aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.
Detailed description
To date, invasive clinician-collected cervical samples, blood, and vaginal samples are still the primary methods to monitor disease and immune responses to vaccine-preventable genital tract infections. Replacing these samples with a specimen that is non-invasive and can be self-collected at home could have important acceptance and feasibility advantages and could facilitate the logistics of clinical trials and future epidemiological studies. Initial results of experiments using first-void urine samples for immune response monitoring are promising. However, overall standardization and normalization of fluctuation in signals are necessary for it to become a suitable genital tract liquid biopsy in vaccine research. Therefore, the aim of this study is to normalize antibody detection in first-void urine by reducing sample variability, using the human papillomavirus (HPV) as a model.
A total of 150 participants will be included, consisting of six different cohorts, including a group of pre-adolescent girls (n=25), a group of young women using ovulation-influencing contraceptives (n=25), a group of young women using non-ovulation-influencing contraceptives (n=25), a group of young women using no contraceptives (n=25), a group of post-menopausal women (n=25), and a group of men (n=25). Participants will be followed over a period of 36 days, and will be asked to self-collect 6 to 21 first-void urine samples (depending on cohort) using a Colli-Pee 20mL (Novosanis). Moreover, participants will have two scheduled visits (day 1 and 36 of the study) at the study site, where each time a blood collection (1x 5-10cc) will be performed.
Collected first-void urine and serum samples will be analyzed for menstrual cycle-related fluctuations and between-group differences in HPV-specific antibody levels. Moreover, to compare immunological with viral endpoints, HPV DNA detection and genotyping will be performed on the first-void urine sample and samples will be tested for various biomarkers that might be valuable for the normalization of inter- and intra-individual variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pre-adolescent group | – | Device: SamplingDefined as girls between 9 and 14 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not yet menstruating (pre-menarche). |
| Ovulatory group | – | Device: SamplingDefined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not using any hormone- or ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle. |
| Ovulation-influencing contraceptive group | – | Device: SamplingDefined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle (including oral contraceptives, hormonal ring, contraceptive injection, contraceptive patch, hormonal implant). |
| Non-ovulation-influencing contraceptive group | – | Device: SamplingDefined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using contraceptives that do not affect ovulation (i.e. intrauterine devices). |
| Post-menopausal group | – | Device: SamplingDefined as fully vaccinated women between 50 and 70 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and have had no menses for at least one year. |
| Male group | – | Device: SamplingDefined as fully vaccinated men between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine. |
Who may qualify
- Ages
- 9 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 150 participants will be included, consisting of six different cohorts, including a group of pre-adolescent girls (n=25), a group of young women using ovulation-influencing contraceptives (n=25), a group of young women using non-ovulation-influencing contraceptives (n=25), a group of young women using no contraceptives (n=25), a group of post-menopausal women (n=25), and a group of men (n=25).
Key inclusion criteria (3 listed)
- Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this.
- Able to understand the information brochure and what the study is about.
- Willing to give informed consent to contact his/her general practitioner and/or gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).
Key exclusion criteria (5 listed)
- Participating in another clinical trial at the same time of participating in this study.
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment.
- Pregnant women.
- Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- Having 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 individual to participate, in the opinion of the investigator.
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 |
|---|---|---|
| SamplingCollection of first-void urine (i.e. the initial stream of the urine) with the Colli-Pee device (Novosanis, Belgium) (6-21 samples over a period of 36 days). Collection of blood samples (2 samples, at day 1 and 36 of the study). | Device | Male group, Non-ovulation-influencing contraceptive group, Ovulation-influencing contraceptive group, Ovulatory group, Post-menopausal group, Pre-adolescent group |
Primary outcome
Concentration of total and HPV-specific IgG (immunoglobulin G) in first-void urine.
Time frame: Within six months after completion of the study
To follow-up levels of total and HPV-specific antibodies in first-void urine at repeated measurements and compare levels of total and HPV-specific antibodies in first-void urine between young men, pre-adolescent girls, post-menopausal women, and women on a contraceptive or ovulatory cycle.
3 secondary outcomes
Concentration of total and HPV-specific IgG (immunoglobulin G) in serum.
Time frame: Within six months after completion of the study
HPV DNA status of first-void urine samples.
Time frame: Within six months after completion of the study
Other biomarkers/analyses.
Time frame: Within six months after completion of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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. This study is not recruiting at the moment.
Wiebren Tjalma, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Vorsters, Professor (+3232659130, alex.vorsters@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of total and HPV-specific IgG (immunoglobulin G) in first-void urine. (time frame: Within six months after completion of the study). 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 3 Sep 2024.