Clinical trial · Observational
Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)
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
NCT02714127CI-TRIAL-00028141BM-SOPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervicovaginal lavage fluid collection | Other | — | UNRESOLVED |
| First-void urine collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- 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.
- interventionNames
- Other: First-void urine collection
- Other: Cervicovaginal lavage fluid collection
- label
- Controls
- description
- 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.
- interventionNames
- Other: First-void urine collection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.