The Phenomenon of the Decrease in the Electrical Resistance Within the Conducting Chambers, Making the Increase in a Conducting PropertyNCT06211010
The Target Urine VOCs Biosensor for Genitourinary Malignancy Detection
An observational study of The Phenomenon of the Decrease in the Electrical Resistance Within the Conducting Chambers, Making the Increase in a Conducting Property, run by Suranaree University of Technology at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Phenomenon of the Decrease in the Electrical Resistance Within the Conducting Chambers, Making the Increase in a Conducting Property
- What is being tested?
- the semiconductor metal oxide sensors.
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2021to 1 Nov 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pateints at Nephrology and Urology clinic of Suranaree University of Technology
Who may be able to join
- Age > 16 years
Who cannot join
- The patients with the renal diseases and the normal subjects were prohibited to have strong odor food
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Institute of Medicine, Suranaree University of Technology
Nakhon Ratchasima, 30000
About this study
Official title: The Urinary Cancer Detection by the Target Urine Volatile Organic Compounds Biosensor
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.
Read the detailed description
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/).
- Being tested
- the semiconductor metal oxide sensors.
- Keywords
- Volatile Organic Compounds (VOCs), Biosensor, Genitourinary Cancer
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the semiconductor metal oxide sensors.Diagnostic test
Also called The detailed products and basic semiconductor circuits are available in the Figaro Product Information Manual (https://www.figarosensor.com/product/sensor/).
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the Target Urine Volatile Organic Compounds from urinary cancers
urine VOCs for detecting genitourinary cancers
Measured: DEC 2021-SEP 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Dec 2021
- Primary completion1 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Phenomenon of the Decrease in the Electrical Resistance Within the Conducting Chambers, Making the Increase in a Conducting PropertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Suranaree University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHATCHAI, Suranaree University of Technology
- Investigators
- Chatchai Kreepala, M.D., Principal investigator, School of Internal Medicine, Institute of Medicine, Suranaree University of Technology, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211010
- Sponsor's protocol ID
- EC-64-109
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: pateints' name and hospital numbers were not indebtifed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Urinary Cancer Detection by the Target Urine Volatile Organic Compounds Biosensor
- ClinicalTrials.gov ID
- NCT06211010
- Acronym / sponsor ID
- EC-64-109
- Keywords
- Volatile Organic Compounds (VOCs), Biosensor, Genitourinary Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suranaree University of TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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/).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pateints at Nephrology and Urology clinic of Suranaree University of Technology
Key inclusion criteria (1 listed)
- Age > 16 years
Key exclusion criteria (1 listed)
- The patients with the renal diseases and the normal subjects were prohibited to have strong odor food
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the semiconductor metal oxide sensors.Also: The detailed products and basic semiconductor circuits are available in the Figaro Product Information Manual (https://www.figarosensor.com/product/sensor/).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. | Diagnostic test | – |
Primary outcome
the Target Urine Volatile Organic Compounds from urinary cancers
Time frame: DEC 2021-SEP 2023
urine VOCs for detecting genitourinary cancers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No. pateints' name and hospital numbers were not indebtifed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chatchai Kreepala, M.D. principal investigator
School of Internal Medicine, Institute of Medicine, Suranaree University of Technology, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Phenomenon of the Decrease in the Electrical Resistance Within the Conducting Chambers, Making the Increase in a Conducting Property, run by Suranaree University of Technology at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Target Urine Volatile Organic Compounds from urinary cancers (time frame: DEC 2021-SEP 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.