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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05453591
Other study ID # RECO_CT29B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2022
Est. completion date April 2024

Study information

Verified date March 2023
Source Novosanis NV
Contact Stephanie Jordaens, PhD student
Phone +32497610800
Email stephanie.jordaens@novosanis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate and possibly validate urinary biomarkers for breast cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well. This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with breast cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 2024
Est. primary completion date December 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: diagnosed with breast cancer Exclusion Criteria: - For cancer patients: suffering from a blood cancer - For healthy volunteers: diagnosed with 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 Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR. Comparison of target detection measured using ddPCR assays [positive, negative or copies/µL] in first-void urine samples from breast cancer patients compared to age- and sex-matched healthy volunteers. (Proof of concept study) Through study completion, an average of 1 year.
Secondary Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast 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
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