Clinical trial NCT05453604: Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications
Official title: Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Urine
Liquid Biopsy
Keywords: Urine
Liquid biopsy
Oncology
Colli-Pee
Lead sponsor: Novosanis NV
Sponsor class: INDUSTRY
Collaborators: name: Universiteit Antwerpen
First posted: 2022-07-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: General DNA or RNA concentration measured using Qubit
timeFrame: Through study completion, an average of 1 year.
measure: Protein concentration measured using ELISA
timeFrame: Through study completion, an average of 1 year.
measure: cell-free DNA or RNA percentages and profiles measured using TapeStation
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 1 year
measure: Usability characteristics of the Colli-Pee UAS devices.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair ziekenhuis Antwerpen
state: Antwerpen
Study officials:
References: