NCT06211010

Brief Summary

Volatile organic compounds (VOCs) have grown due to their crucial role in transitioning from invasive to noninvasive cancer diagnostic methods. This study aimed to assess the feasibility of the metal oxide biosensor platform using urine VOCs for detecting genitourinary cancers. Five different commercially available semiconductor sensors were chosen to detect specific VOCs (methane, iso-butane, hydrogen, ethanol, hydrogen sulfide, ammonia, toluene, butane, propane, trimethylamine, and methyl-mercaptan). Changes in electrical resistance due to temperature variations from the voltage heater were examined to characterize VOC metabolism. Logistic regression and ROC analysis were employed to evaluate potential urine VOCs for genitourinary cancer determination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

January 8, 2024

Last Update Submit

January 8, 2024

Conditions

Keywords

Volatile Organic Compounds (VOCs)BiosensorGenitourinary Cancer

Outcome Measures

Primary Outcomes (1)

  • the Target Urine Volatile Organic Compounds from urinary cancers

    urine VOCs for detecting genitourinary cancers

    DEC 2021-SEP 2023

Interventions

The method of analyzing the VOCs was through analyzing the evaporated VOCs from the urine in the container when they evaporated into the sealed chamber. The VOCs in the chamber were then analyzed at the same time by the five different gas semiconductor sensors which were located on the top of the chamber.

Also known as: The detailed products and basic semiconductor circuits are available in the Figaro Product Information Manual (https://www.figarosensor.com/product/sensor/).

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pateints at Nephrology and Urology clinic of Suranaree University of Technology

You may qualify if:

  • Age \> 16 years

You may not qualify if:

  • The patients with the renal diseases and the normal subjects were prohibited to have strong odor food

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medicine, Suranaree University of Technology

Nakhon Ratchasima, 30000, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh Urine sample 20 mL for a pateint

MeSH Terms

Conditions

Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Chatchai Kreepala, M.D.

    School of Internal Medicine, Institute of Medicine, Suranaree University of Technology, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr. Chatchai Kreepala, M.D.

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

December 1, 2021

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

pateints' name and hospital numbers were not indebtifed.

Locations