NCT02156180

Brief Summary

In this study the Investigators aim to determine specific volatile compounds present in breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma before and after tumour resection or before and after chemotherapy +/- radiotherapy using gas chromotography-mass spectrometry. The Investigators hypothesize that study participants with a tumour will display a distinct set of volatile organic compounds than can serve as potential cancer biomarkers.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

June 3, 2014

Last Update Submit

April 20, 2015

Conditions

Oral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell Carcinoma

Keywords

exhaled breathvolatile organic compoundssurgerychemotherapyradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Presence of volatile organic compounds in breath samples if patients with oral cavity or oropharyngeal squamous cell carcinoma

    Breath samples of patients with oral cavity or oropharyngeal squamous cell carcinoma will be compared before treatment - surgery or radiotherapy/chemotherapy, and then one month after completion of treatment - surgery or radiotherapy/chemotherapy

    Approximately 1-4 months

Study Arms (1)

Early stage oral cavity / oropharyngeal cancer

Exhaled breath

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who attend the Head and Neck Cancer Clinic at the Princess Alexandra Hospital, Brisbane, Australia

You may qualify if:

  • Age 18-90 years
  • Clinical diagnosis of oral cavity or oropharyngeal squamous cell carcinoma

You may not qualify if:

  • Evidence of metastatic disease
  • Previous treatment of this cancer with surgery, chemotherapy or radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Related Publications (5)

  • Willis CM, Church SM, Guest CM, Cook WA, McCarthy N, Bransbury AJ, Church MR, Church JC. Olfactory detection of human bladder cancer by dogs: proof of principle study. BMJ. 2004 Sep 25;329(7468):712. doi: 10.1136/bmj.329.7468.712.

    PMID: 15388612BACKGROUND

  • Chan HP, Lewis C, Thomas PS. Exhaled breath analysis: novel approach for early detection of lung cancer. Lung Cancer. 2009 Feb;63(2):164-8. doi: 10.1016/j.lungcan.2008.05.020. Epub 2008 Jul 2.

    PMID: 18599152BACKGROUND

  • Lippi G. Re: Jean-Nicolas Cornu,Geraldine Cancel-Tassin, Valerie Ondet, et Al. Olfactory detection of prostate cancer by dogs sniffing urine: a step forward in early diagnosis. Eur urol 2011; 59: 197-201. Eur Urol. 2011 Oct;60(4):e29; author reply e30. doi: 10.1016/j.eururo.2011.06.030. Epub 2011 Jun 22. No abstract available.

    PMID: 21726935BACKGROUND

  • Badjagbo K. Exhaled breath analysis for early cancer detection: principle and progress in direct mass spectrometry techniques. Clin Chem Lab Med. 2012 Nov;50(11):1893-1902. doi: 10.1515/cclm-2012-0208.

    PMID: 22718640BACKGROUND

  • Dobrossy L. Epidemiology of head and neck cancer: magnitude of the problem. Cancer Metastasis Rev. 2005 Jan;24(1):9-17. doi: 10.1007/s10555-005-5044-4.

    PMID: 15785869BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Jae Lim, Dr

    Princess Alexandra Hospital

    PRINCIPAL INVESTIGATOR

  • Ben Panizza, Assoc Prof

    Princess Alexandra Hospital

    PRINCIPAL INVESTIGATOR

  • Vince Alberts, Mr

    Queensland Health Forensic and Scientific Services

    PRINCIPAL INVESTIGATOR

  • Jeff Herse, Mr

    Queensland Health Forensic and Scientific Services

    PRINCIPAL INVESTIGATOR

  • David Pass, Mr

    Queensland Health Forensic and Scientific Services

    PRINCIPAL INVESTIGATOR

  • Nigel Brown, Dr

    Princess Alexandra Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

AU(1)