AzTrials
AzTrials

Lung CancerNCT01660087

Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device

A study testing Biophotonic platform for VOC detection in people with Lung Cancer, run by National University Hospital, Singapore at 2 sites in Singapore.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The overall objective of this proposal is to develop a non-invasive, inexpensive and accurate device that detects VOCs in exhaled breath for lung cancer screening. Toward this goal, the team will design and fabricate a biophotonic platform consists of arrays of silicon micro-ring resonator sensors coated with polymers… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Lung Cancer
What is being tested?
Biophotonic platform for VOC detection
Type of treatment
Medical device
How many people
0 participants
Where
2 sitesSingapore
Study dates
Apr 2012to 30 Sep 2015
Phase
Interventional
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.

Who cannot join

  • Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

  • Institute of Microelectronics

    Singapore, Singapore, 117685

  • National University Hospital/ National University of Singapore

    Singapore, Singapore, 119074

Other trials in Singapore

About this study

Official title: Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device.

The overall objective of this proposal is to develop a non-invasive, inexpensive and accurate device that detects VOCs in exhaled breath for lung cancer screening. Toward this goal, the team will design and fabricate a biophotonic platform consists of arrays of silicon micro-ring resonator sensors coated with polymers with different organic functionalities, in which each sensor is widely responsive to a variety of VOCs for the detection of lung cancer by means of breath testing. The team will identify signature VOCs as lung cancer biomarkers by comparison VOC contents between alveolar gas that directly sampled from the nodule or mass and exhaled breath using gas chromatography/ mass spectrometry.

The specific aims of this proposal are as followings:

Read more

Aim 1: To develop a biophotonic platform for the detection of VOCs

Aim 2: To achieve multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device.

Aim 3: To evaluate the device as a lung cancer screening tool by testing both healthy and lung cancer breath samples

Read the detailed description

Lung cancer is the leading cause of cancer deaths throughout the world and accounts for more than 1.2M new cases worldwide annually, making lung cancer one of the most serious public health problems in industrialized countries. Up to date there is no valid screening method for lung cancer. Thus it is often diagnosed at an advance stage when treatment is less effective, which consequantly leads to high mortality rate. However, with early diagnosis and treatment, the 5-year survival rate improves dramatically from 1% in stage 4, 20% in stage 3 to 70% in stage 1 disease. Therefore early diagnosis plays a pivotal role in improving survival for this otherwise uniformly fatal disease. In recently studies, it was found that some of the products of metabolism, called volatile organic comounds (VOCs), are carried in the breath and can serve as biomarkers. Cancer cells produce different types of VOCs than normal cells do. More importantly, these VOC markers can be found in exhaled breath for cancer stages 1 through 4.

Combining the strength of IME's in the biophotonics, the research groups at NUS in basic science and the NUH clinician's knowledge and expertise in lung cancer, this proposal is aiming to tackle the challenge of lung cancer screening by developing a non-invasive, inexpensive, and accurate sensor platform to detect VOCs in exhaled breath. The device will consists of arrays of silicon micro-ring resonator sensors coated with polymers with different organic functionalities, in which each sensor is widely responsive to a variety of VOCs. In this proposal, we plan to build a prototype device and test for the detection of VOCs in exhaled breath from healthy controls and lung cancer patients. The successful outcome of this proposal would have an immense impact on lung cancer management by enabling an early stage cancer screening.

Conditions
Lung Cancer
Being tested
Biophotonic platform for VOC detection
Keywords
Exhaled breath condensate (EBC) method, Volatile Organic Compounds (VOCs), Endobronchial Ultrasound (EBUS), Confocal Endoscopy, Exhaled alveolar gas
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biophotonic platform for VOC detectionDevice

    Multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2012 (estimated)
  2. Study startApr 2012
  3. Primary completion30 Sep 2015
  4. Study completion30 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01660087
Sponsor's protocol ID
SERC/1121480001
Status last verified
Apr 2017
First submitted
6 Aug 2012
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.

    PubMed 20610543

  • International Early Lung Cancer Action Program Investigators; Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 10.1056/NEJMoa060476.

    PubMed 17065637

  • Sit AK, Sihoe AD, Suen WS, Cheng LC. Positron-emission tomography for lung cancer in a tuberculosis-endemic region. Asian Cardiovasc Thorac Ann. 2010 Feb;18(1):33-8. doi: 10.1177/0218492309352119.

    PubMed 20124294

  • Mahadevia PJ, Fleisher LA, Frick KD, Eng J, Goodman SN, Powe NR. Lung cancer screening with helical computed tomography in older adult smokers: a decision and cost-effectiveness analysis. JAMA. 2003 Jan 15;289(3):313-22. doi: 10.1001/jama.289.3.313.

    PubMed 12525232

  • Phillips M, Gleeson K, Hughes JM, Greenberg J, Cataneo RN, Baker L, McVay WP. Volatile organic compounds in breath as markers of lung cancer: a cross-sectional study. Lancet. 1999 Jun 5;353(9168):1930-3. doi: 10.1016/S0140-6736(98)07552-7.

    PubMed 10371572

  • Phillips M, Cataneo RN, Cummin AR, Gagliardi AJ, Gleeson K, Greenberg J, Maxfield RA, Rom WN. Detection of lung cancer with volatile markers in the breath. Chest. 2003 Jun;123(6):2115-23. doi: 10.1378/chest.123.6.2115.

    PubMed 12796197

  • Mazzone PJ. Analysis of volatile organic compounds in the exhaled breath for the diagnosis of lung cancer. J Thorac Oncol. 2008 Jul;3(7):774-80. doi: 10.1097/JTO.0b013e31817c7439.

    PubMed 18594325

  • Filipiak W, Sponring A, Mikoviny T, Ager C, Schubert J, Miekisch W, Amann A, Troppmair J. Release of volatile organic compounds (VOCs) from the lung cancer cell line CALU-1 in vitro. Cancer Cell Int. 2008 Nov 24;8:17. doi: 10.1186/1475-2867-8-17.

    PubMed 19025629

  • Phillips M, Altorki N, Austin JH, Cameron RB, Cataneo RN, Greenberg J, Kloss R, Maxfield RA, Munawar MI, Pass HI, Rashid A, Rom WN, Schmitt P. Prediction of lung cancer using volatile biomarkers in breath. Cancer Biomark. 2007;3(2):95-109. doi: 10.3233/cbm-2007-3204.

    PubMed 17522431

  • Di Natale C, Macagnano A, Martinelli E, Paolesse R, D'Arcangelo G, Roscioni C, Finazzi-Agro A, D'Amico A. Lung cancer identification by the analysis of breath by means of an array of non-selective gas sensors. Biosens Bioelectron. 2003 Sep;18(10):1209-18. doi: 10.1016/s0956-5663(03)00086-1.

    PubMed 12835038

  • Mazzone PJ, Hammel J, Dweik R, Na J, Czich C, Laskowski D, Mekhail T. Diagnosis of lung cancer by the analysis of exhaled breath with a colorimetric sensor array. Thorax. 2007 Jul;62(7):565-8. doi: 10.1136/thx.2006.072892. Epub 2007 Feb 27.

    PubMed 17327260

  • Peng G, Trock E, Haick H. Detecting simulated patterns of lung cancer biomarkers by random network of single-walled carbon nanotubes coated with nonpolymeric organic materials. Nano Lett. 2008 Nov;8(11):3631-5. doi: 10.1021/nl801577u. Epub 2008 Oct 8.

    PubMed 18839997

  • Machado RF, Laskowski D, Deffenderfer O, Burch T, Zheng S, Mazzone PJ, Mekhail T, Jennings C, Stoller JK, Pyle J, Duncan J, Dweik RA, Erzurum SC. Detection of lung cancer by sensor array analyses of exhaled breath. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1286-91. doi: 10.1164/rccm.200409-1184OC. Epub 2005 Mar 4.

    PubMed 15750044

  • Peng G, Tisch U, Adams O, Hakim M, Shehada N, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Haick H. Diagnosing lung cancer in exhaled breath using gold nanoparticles. Nat Nanotechnol. 2009 Oct;4(10):669-73. doi: 10.1038/nnano.2009.235. Epub 2009 Aug 30.

    PubMed 19809459

  • Carlborg CF, Gylfason KB, Kazmierczak A, Dortu F, Banuls Polo MJ, Maquieira Catala A, Kresbach GM, Sohlstrom H, Moh T, Vivien L, Popplewell J, Ronan G, Barrios CA, Stemme G, van der Wijngaart W. A packaged optical slot-waveguide ring resonator sensor array for multiplex label-free assays in labs-on-chips. Lab Chip. 2010 Feb 7;10(3):281-90. doi: 10.1039/b914183a. Epub 2009 Nov 12.

    PubMed 20090999

Questions about this trial

What is this clinical trial studying?

A study testing Biophotonic platform for VOC detection in people with Lung Cancer, run by National University Hospital, Singapore at 2 sites in Singapore.

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: withdrawn, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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 was withdrawn before enrolling participants, so there are no results.

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?

Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01660087, which also lists 15 linked publications.

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 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in