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

NCT02714127 | Completed

• 1 other identifier: B300201525585
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Human Papillomavirus; Biomarker; Self-sampling; First-void urine; Cervicovaginal fluid; Colposcopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 months after study completion

Secondary Outcomes (2)

• Preference of women for self-sampling methods

  Within 6 months after study completion

• Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine

  Within 6 months after study completion

Study Arms (2)

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; 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.

Other: First-void urine collection; Other: Cervicovaginal lavage fluid collection

Interventions

First-void urine collection OTHER

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).

Also known as: FV urine

Cases; Controls

Cervicovaginal lavage fluid collection OTHER

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.

Also known as: VagLav

Cases; Controls

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Female
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Research Foundation Flanders: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (1)

Wiebren Tjalma

Edegem, Antwerp, 2650, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples and Cervicovaginal lavage fluid (VagLav) samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Pierre Van Damme, Prof MD PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pierre Van Damme, MD, PhD

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 21, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)