Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05453604
Other study ID # 2019_NOV_CP_001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 18, 2020
Est. completion date December 2023

Study information

Verified date November 2023
Source Novosanis NV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods. This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being at least 18 years old - Being able to understand and read Dutch - For cancer patients specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer) Exclusion Criteria: - For cancer patients specifically: patients suffering from a blood cancer

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Colli-Pee UAS devices
Colli-Pee UAS device variants will be evaluated during this study

Locations

Country Name City State
Belgium Universitair ziekenhuis Antwerpen Edegem Antwerpen

Sponsors (2)

Lead Sponsor Collaborator
Novosanis NV Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary General DNA or RNA concentration measured using Qubit Comparison of DNA or RNA concentrations [ng/µL] measured using Qubit assays
between different extraction methods;
between different first-void urine volumes (10, 20, 40 mL);
between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Through study completion, an average of 1 year.
Primary Protein concentration measured using ELISA Comparison of protein concentrations measured using ELISA assays
between different extraction methods;
between different first-void urine volumes (10, 20, 40 mL);
between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Through study completion, an average of 1 year.
Primary cell-free DNA or RNA percentages and profiles measured using TapeStation Comparison of cell-free DNA or RNA percentages (%) and profiles (graphical) measured using TapeStation assays
between different extraction methods;
between different first-void urine volumes (10, 20, 40 mL);
between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Through study completion, an average of 1 year
Primary Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate cancer patients measured using ddPCR Comparison of target detection measured using ddPCR assays [copies/µL]
between different extraction methods;
between different first-void urine volumes (10, 20, 40 mL];
between different storage conditions (Day 0, Day 7, Day 14 at room temperature).
Through study completion, an average of 1 year
Secondary Detection (presence/absence) of specific biomarker targets (SRY, HER2, PIK3CA, AR-V7, TMPRSS2-ERG) for pregnant women, breast cancer patients and prostate cancer patients measured using ddPCR. Comparison of target detection measured using ddPCR assays [positive, negative or copies/µL] in first-void urine samples from all study participants compared to blood testing using ddPCR. (Proof of concept study) Through study completion, an average of 1 year
Secondary Usability characteristics of the Colli-Pee UAS devices. All study participants will receive a questionnaire regarding the usability characteristic of the Colli-Pee UAS devices. These questions cover physical information, previous experiences, and usability questions. When scores need to be given participants can score between 0 and 100%, in which 0% is a negative score and 100% is a positive score. When an opinion is asked participants can choose between very difficult, difficult, neutral, easy, and very easy. Analysis will be done using descriptive statistics. Through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A