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Lung Neoplasms

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Trial Information


Among all cancers which harm the population, lung cancer is the most lethal type,
responsible for 1.3 million deaths per year worldwide, for 28% of all cancer deaths.The 5
year survival rates are low, only 15%.

Diagnosis and treatment of lung cancer in its early stages could increase the
5-year-survival rate by 3-4 fold with a potential for cure. Therefore, efforts are being
made to develop new sensitive specified screening tools for detecting lung cancer at its'
earliest stages.

A new emerging strategy for early detection of lung cancer is based on the recognition of
the tumors metabolic signature, on the identification of specific biomarkers for the
disease, such as the volatile organic compounds (VOC). Research has demonstrated that these
compounds are released from the cancerous tissue from the early stages of the disease, and
can be found in different bodily secretions.

The subjects, lung cancer patients and chronic obstructive pulmonary disease (COPD)
patients, would be given cotton T-shirts with instructions to wear them without previously
applying deodorant or any other similar personal hygiene products. Then, the shirts would be
collected and 8 pieces (size:1cm*3cm from the armpit areas) would be cut from each one.

Dogs for this study would be trained by the "Dogs for People" association. In the initial
stage, 40 mixed breed dogs and 3-4 Springer spaniels would be exposed to sweat sample
collected from cancer patients in order to get them acquainted with the scent. Then, it
would be demanded of them to locate boxes containing T-shirt sample taken from cancer
patients, from decoy boxes holding naïve T-shirts. Every sequence will include 4 boxes with
a different ratio between the specimens(each time a different number of boxes will contain
samples taken from cancer patients, 0,1,2,3 or 4 when the rest of the boxes would contain
naïve T-shirts). The dogs would mark the specimen by sitting next to each relevant box (they
will ignore the decoy boxes after sniffing them and identifying them as irrelevant).

The most prominent 8-9 dogs would continue to the experiment phase. Each training course
would last for 5-10 minutes or for 8 successful identifications, depending on the training
dog needs. Dogs would be rewarded with a treat (a dog biscuit) or with play time, depending
on the dogs' nature.

In the experimental phase, the decoy boxes would hold sweat samples collected from COPD
patients instead of naïve T-shirts. The dogs would be asked to locate boxes containing the
T-shirt sample taken from the lung cancer patients, from the decoy boxes. Every sequence
will include 4 boxes with a different ratio between the specimens (each time a different
number of boxes will contain samples taken from cancer patients, 0,1,2,3 or 4 when the rest
of the boxes would contain samples collected from COPD patients). The dogs would mark the
specimen by sitting next to each relevant box (they will ignore the decoy boxes after
sniffing them and identifying them as irrelevant).

The trainer would be oblivious to the targets' location.


Inclusion Criteria:



• A diagnosis of lung cancer, regardless of histology.

Exclusion Criteria

- Inability to comply with study and/or follow up procedure.

- Co morbidity of lung cancer and an additional malignancy combined.

- Patients taking part in another clinical trial and receiving any treatment for it.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Number of patients with lung neoplasms

Outcome Description:

Dogs ability to distinguish between COPD and lung cancer patients sweat samples

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Nir Peled, MD PhD FCCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheba Medical Center

Authority:

Israel: Ministry of Health

Study ID:

SHEBA-11-9031-NP-CTIL

NCT ID:

NCT01527461

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Lung Neoplasms
  • lung neoplasms
  • dogs
  • sweat
  • smell
  • Neoplasms
  • Lung Neoplasms

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