Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)

An observational study of Cervical Cancer, run by Universiteit Antwerpen at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions. Read more about this study

Who is it for?: Ages 25 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer
What is being tested?: First-void urine collection and Cervicovaginal lavage fluid collection
How many people: 128 participants
Where: 1 siteBelgium
Study dates: Sep 2015to Dec 2016
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 25 to 64 years
Women only
Healthy volunteers accepted
Adult

Study population: The cohort of women involves 100 women, diagnosed with an abnormal smear and/or high risk HPV infection (cytology results already available) requested for colposcopic examination. During this colposcopic examination, cervical samples are collected and send to the pathology laboratory. In addition, these women are asked to collect a first-void urine sample with the Colli-PeeTM device and fill in a questionnaire, prior to their colposcopy exam at the clinic (UZA), during which a cervicovaginal lavage fluid sample will be collected as well.

Who may be able to join

Female
25-64 year old
Women scheduled for a colposcopy exam due to abnormal cytology result according to the Bethesda classification 2001 (NILM, AGC (Atypical Glandular Cells), ASC-US (Atypical Squamous Cells of Undetermined Significance), ASC-H (Atypical Squamous Cells - cannot exclude HSIL), LSIL (Low-grade Squamous Intraepithelial Lesion), HSIL (High-grade Squamous Intraepithelial Lesion), invasive carcinoma), and/or positive for hrHPV infection. NILM (Negative for Intraepithelial Lesion or Malignancy) are only included when positive for hrHPV infection.
Signing informed consent form (ICF).
Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).

Who cannot join

Participating in another clinical study at the same time of participating in this study.
Not able to understand the information brochure/what the study is about.
Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Wiebren Tjalma
Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official title: Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine: the BM-SOP Study

Read the detailed description

In total 100 women will be included in this trial, women diagnosed with abnormal cytology results and/or high risk HPV (Human Papillomavirus) infection scheduled for a colposcopy exam. These women are asked to collect a first-void urine sample with the Colli-PeeTM device, prior to their colposcopy exam at the clinic. The collected urine samples will be used for the development and optimisation of robust analytical protocols for first-void urine sample preparation and biomarker assays.

During colposcopy, the cervix will be visually inspected, whether or not combined with a biopsy for histological confirmation. Colposcopy is a procedure to identify abnormalities by using a colposcope that gives an illuminated, magnified view of the cervical region. It often includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). Here, this fluid will be collected and serve as the intermediate step between biomarkers in cervicovaginal secretions and urine.

Conditions: Cervical Cancer
Being tested: First-void urine collection, Cervicovaginal lavage fluid collection
Keywords: Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervicovaginal fluid, Colposcopy
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

First-void urine collectionOther
Also called FV urine
One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).
Cervicovaginal lavage fluid collectionOther
Also called VagLav
During colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.

Study groups in NCT02714127
Study group	Role	What they receive
Cases		Women (25-64 years old) with abnormal cytology results and/or (high risk) HPV infection refered for colposcopy, and hence possibly diagnosed with an (high risk) HPV infection and/or cervical (pre)cancerous lesions. No clinical evaluations/interventions will be performed by our research group. Participants have an already scheduled colposcopy exam. However, this visit is not an extra investigation that the participants should undergo when participating in the study. Receives: Other: First-void urine collection; Other: Cervicovaginal lavage fluid collection
Controls		Healthy women (25-64 years old), falsely diagnosed with abnormal cytology and/or (high risk) HPV infection, but referred for colposcopy, are included as negative controls. Based on a specificity of 76.14% of the HPV type-specific PCR (polymerase chain reaction) used, an estimated 24 out of these 100 participants will be incorrectly scheduled for colposcopy and serve as the control group. No clinical evaluations/interventions will be performed by our research group. Participants have an already scheduled colposcopy exam. However, this visit is not an extra investigation that the participants should undergo when participating in the study. Receives: Other: First-void urine collection; Other: Cervicovaginal lavage fluid collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of cervical cancer biomarkers in first-void urine
To detect candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in first-void urine samples from 100 women scheduled for colposcopy due to abnormal cytology.
Measured: Within 6 months after study completion

Secondary outcomes (2)

Preference of women for self-sampling methods
Gather information about the preference of women for first-void urine sample collection compared to the currently available self-sampling methods, and a clinician collected sample (smear).
Measured: Within 6 months after study completion
Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine
To compare the presence of candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in paired first-void urine and VagLav samples from 100 women scheduled for colposcopy due to abnormal cytology.
Measured: Within 6 months after study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Dec 2016

First posted21 Mar 2016 (estimated)
Study startSep 2015
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancerStudies 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: Case-control
Time perspective: Prospective
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02714127
Sponsor's protocol ID: B300201525585
Acronym: BM-SOP
Status last verified: Jun 2017
First submitted: 10 Mar 2016
Last updated: 15 Jun 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine: the BM-SOP Study
ClinicalTrials.gov ID: NCT02714127
Acronym / sponsor ID: BM-SOP / B300201525585
Conditions: Cervical Cancer
Keywords: Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervicovaginal fluid, Colposcopy
Study type: Observational
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Universiteit AntwerpenUniversity, hospital or other
Collaborators: Research Foundation Flanders, University Hospital, Antwerp
Study start: Sep 2015
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 21 Mar 2016 (estimated)
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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cases	–	Other: First-void urine collection, Other: Cervicovaginal lavage fluid collectionWomen (25-64 years old) with abnormal cytology results and/or (high risk) HPV infection refered for colposcopy, and hence possibly diagnosed with an (high risk) HPV infection and/or cervical (pre)cancerous lesions. No clinical evaluations/interventions will be performed by our research group. Participants have an already scheduled colposcopy exam. However, this visit is not an extra investigation that the participants should undergo when participating in the study.
Controls	–	Other: First-void urine collection, Other: Cervicovaginal lavage fluid collectionHealthy women (25-64 years old), falsely diagnosed with abnormal cytology and/or (high risk) HPV infection, but referred for colposcopy, are included as negative controls. Based on a specificity of 76.14% of the HPV type-specific PCR (polymerase chain reaction) used, an estimated 24 out of these 100 participants will be incorrectly scheduled for colposcopy and serve as the control group. No clinical evaluations/interventions will be performed by our research group. Participants have an already scheduled colposcopy exam. However, this visit is not an extra investigation that the participants should undergo when participating in the study.

Who may qualify

Ages: 25 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: The cohort of women involves 100 women, diagnosed with an abnormal smear and/or high risk HPV infection (cytology results already available) requested for colposcopic examination. During this colposcopic examination, cervical samples are collected and send to the pathology laboratory. In addition, these women are asked to collect a first-void urine sample with the Colli-PeeTM device and fill in a questionnaire, prior to their colposcopy exam at the clinic (UZA), during which a cervicovaginal lavage fluid sample will be collected as well.

Key inclusion criteria (5 listed)

Female
25-64 year old
Women scheduled for a colposcopy exam due to abnormal cytology result according to the Bethesda classification 2001 (NILM, AGC (Atypical Glandular Cells), ASC-US (Atypical Squamous Cells of Undetermined Significance), ASC-H (Atypical Squamous Cells - cannot exclude HSIL), LSIL (Low-grade Squamous Intraepithelial Lesion), HSIL (High-grade Squamous Intraepithelial Lesion), invasive carcinoma), and/or positive for hrHPV infection. NILM (Negative for Intraepithelial Lesion or Malignancy) are only included when positive for hrHPV infection.
Signing informed consent form (ICF).
Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).

Key exclusion criteria (3 listed)

Participating in another clinical study at the same time of participating in this study.
Not able to understand the information brochure/what the study is about.
Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

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
First-void urine collectionAlso: FV urineOne time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).	Other	Cases, Controls
Cervicovaginal lavage fluid collectionAlso: VagLavDuring colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.	Other	Cases, Controls

Primary outcome

Concentration of cervical cancer biomarkers in first-void urine
Time frame: Within 6 months after study completion
To detect candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in first-void urine samples from 100 women scheduled for colposcopy due to abnormal cytology.

2 secondary outcomes

Preference of women for self-sampling methods
Time frame: Within 6 months after study completion
Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine
Time frame: Within 6 months after study completion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
Individual participant dataSharing planned: No

Related trials for Cervical Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

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.

Pierre Van Damme, Prof 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?

An observational study of Cervical Cancer, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jun 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of cervical cancer biomarkers in first-void urine (time frame: Within 6 months after study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714127.

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 15 Jun 2017.