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Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications

NCT05453604 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-11-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Colli-Pee UAS devices

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

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • Novosanis NV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453604 on ClinicalTrials.gov