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Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications (URODETECT-WP1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05453604
Recruitment Status : Recruiting
First Posted : July 12, 2022
Last Update Posted : July 12, 2022
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Novosanis NV

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Urine Liquid Biopsy Device: Colli-Pee UAS devices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sample collection
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.
Device: Colli-Pee UAS devices
Colli-Pee UAS device variants will be evaluated during this study




Primary Outcome Measures :
  1. General DNA or RNA concentration measured using Qubit [ Time Frame: Through study completion, an average of 1 year. ]

    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).

  2. Protein concentration measured using ELISA [ Time Frame: Through study completion, an average of 1 year. ]

    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).

  3. cell-free DNA or RNA percentages and profiles measured using TapeStation [ Time Frame: Through study completion, an average of 1 year ]

    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).

  4. 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 [ Time Frame: Through study completion, an average of 1 year ]

    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).


Secondary Outcome Measures :
  1. 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. [ Time Frame: Through study completion, an average of 1 year ]
    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)

  2. Usability characteristics of the Colli-Pee UAS devices. [ Time Frame: Through study completion, an average of 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT05453604


Contacts
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Contact: Stephanie Jordaens, PhD student +32497610800 stephanie.jordaens@novosanis.com

Locations
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Belgium
Universitair ziekenhuis Antwerpen Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Tjalma, Prof. Dr.    +32 3 821 32 50    borstkliniek@uza.be   
Sponsors and Collaborators
Novosanis NV
Universiteit Antwerpen
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Responsible Party: Novosanis NV
ClinicalTrials.gov Identifier: NCT05453604    
Other Study ID Numbers: 2019_NOV_CP_001
First Posted: July 12, 2022    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novosanis NV:
Urine
Liquid biopsy
Oncology
Colli-Pee
Additional relevant MeSH terms:
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Neoplasms