Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01660087
• Other study ID #: SERC/1121480001
• Status: Withdrawn
• Phase: N/A
• First received: August 6, 2012
• Last updated: April 16, 2017
• Start date: April 2012
• Est. completion date: September 30, 2015

Study information

• Verified date: April 2017
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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:

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Biophotonic platform for VOC detection
Multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device.

Locations

Country	Name	City	State
Singapore	Institute of Microelectronics	Singapore
Singapore	National University Hospital/ National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (15)

Carlborg CF, Gylfason KB, Kazmierczak A, Dortu F, Bañuls Polo MJ, Maquieira Catala A, Kresbach GM, Sohlström 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. — View Citation

Di Natale C, Macagnano A, Martinelli E, Paolesse R, D'Arcangelo G, Roscioni C, Finazzi-Agrò 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. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2008 Apr 24;358(17):1875. N Engl J Med. 2008 Apr 24;358(17):1862. N Engl J Med. 2008 Aug 21;359(8):877. — View Citation

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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):133-4. — View Citation

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. Epub 2005 Mar 4. — View Citation

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. — View Citation

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. Epub 2007 Feb 27. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.