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

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ClinicalTrials.gov Identifier: NCT02714127
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : June 15, 2017
Sponsor:
Collaborators:
Research Foundation Flanders
University Hospital, Antwerp
Information provided by (Responsible Party):
Pierre Van Damme, Universiteit Antwerpen

Brief 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.

Condition or disease Intervention/treatment
Cervical Cancer Other: First-void urine collection Other: Cervicovaginal lavage fluid collection

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.

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Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Other: First-void urine collection
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).
Other Name: FV urine

Other: Cervicovaginal lavage fluid collection
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.
Other Name: VagLav

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.

Other: First-void urine collection
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).
Other Name: FV urine

Other: Cervicovaginal lavage fluid collection
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.
Other Name: VagLav




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Preference of women for self-sampling methods [ Time Frame: Within 6 months after study completion ]
    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).

  2. Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine [ Time Frame: Within 6 months after study completion ]
    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.


Biospecimen Retention:   Samples With DNA
First-void urine samples and Cervicovaginal lavage fluid (VagLav) samples


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714127


Locations
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Belgium
Wiebren Tjalma
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Universiteit Antwerpen
Research Foundation Flanders
University Hospital, Antwerp
Investigators
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Principal Investigator: Pierre Van Damme, Prof MD PhD Universiteit Antwerpen
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Responsible Party: Pierre Van Damme, Professor Pierre Van Damme, MD, PhD, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02714127    
Other Study ID Numbers: B300201525585
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pierre Van Damme, Universiteit Antwerpen:
Human Papillomavirus
Biomarker
Self-sampling
First-void urine
Cervicovaginal fluid
Colposcopy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases