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

NCT05453604 | Unknown

• 1 other identifier: 2019_NOV_CP_001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Prostate Cancer; Urine; Liquid Biopsy

Keywords

Urine; Liquid biopsy; Oncology; Colli-Pee

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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

• 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 Outcomes (2)

• 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.

  Through study completion, an average of 1 year

• Usability characteristics of the Colli-Pee UAS devices.

  Through study completion, an average of 1 year

Study Arms (1)

Sample collection

EXPERIMENTAL

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

Interventions

Colli-Pee UAS devices DEVICE

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

Sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• For cancer patients specifically: patients suffering from a blood cancer

Sponsors & Collaborators

• Novosanis NV: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Universitair ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 12, 2022
• Study Start: June 18, 2020
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)