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Completed

NCT Number: NCT06211010

The Target Urine VOCs Biosensor for Genitourinary Malignancy Detection

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medicine, Suranaree University of Technology

Nakhon Ratchasima, 30000, Thailand

About this study

Nowadays, the development of semiconductor metal oxide sensors allows the detection of VOCs from breath and urine by relying on the change of voltage and electrical resistance. The studies use electric current to evaporate VOCs and focus on the changes of evaporation at different temperatures. The results from the previous studies have shown that the changes in the voltage and electrical current resistance dynamics in the semiconductor metal oxide sensors indicate specific patterns that are specific to different types of VOCs. Therefore, this could transit the odor-fingerprint in biogas expression platform to the electrical expression platform due to the possibility of specific-disease VOC identification and the cost-effectiveness of the electrical expression platform when compared to SPME and GC-MS.

This is a descriptive cohort study conducted among 64 subjects attending outpatient clinic at during August 2021 to July 2023. All the subjects were advised and voluntarily signed a consent form before participating in our study. The patients with the renal diseases and the normal subjects were prohibited to have strong odor food (such as tea, coffee, onion, garlic, shrimp paste, acacia, fermented fish, pakria, and celery, etc.) for at least 3 hours before the examination of urine VOCs and were prohibited alcohol intakes for more than 24 hours prior to the urine VOCs examination. The urine samples were collected for 20 mL in universal bottles and samples were classified as genitourinary (kidney/bladder/prostate) cancer or non-cancer or normal control after pathological examination of the biopsy specimens. The urine samples were kept at room temperature and taken to be analyzed with the semiconductor sensors within 30 minutes after the samples were collected.

We selected five different commercially available semiconductor metal oxide sensors to detect all the targeted VOCs, which are methane, iso-butane, hydrogen, ethanol, hydrogen sulfide, ammonia, toluene, butane, propane, trimethylamine, methyl-mercaptan (manufactured by Figaro company). These are the types of VOCs which had been studied and were shown to be related to the malignant according to the literature. The detailed products and basic semiconductor circuits are available in the Figaro Product Information Manual (https://www.figarosensor.com/product/sensor/).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 16 years

Exclusion criteria

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

Treatment and study plan

the semiconductor metal oxide sensors.

Diagnostic Test

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.

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

Primary outcomes

  1. the Target Urine Volatile Organic Compounds from urinary cancers

    Time frame: DEC 2021-SEP 2023

    urine VOCs for detecting genitourinary cancers

Sponsors and collaborators

Lead sponsor

Suranaree University of Technology

Other

Registry information

Official study title

The Urinary Cancer Detection by the Target Urine Volatile Organic Compounds Biosensor

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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