Identifying Unique Scent Signature of Lung Cancer Through Body Odor
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|ClinicalTrials.gov Identifier: NCT01527461|
Recruitment Status : Unknown
Verified June 2013 by Dr. Nir Peled MD, PhD, Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : February 7, 2012
Last Update Posted : June 4, 2013
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Study Start Date :||February 2012|
Lung Cancer Patients
diagnosed lung cancer patients .
COPD patients, not diagnosed with lung cancer.
- Number of patients with lung neoplasms [ Time Frame: one year ]Dogs ability to distinguish between COPD and lung cancer patients sweat samples
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527461
|Contact: Nir Peled, MD PhD FCCPfirstname.lastname@example.org|
|Contact: Michal Alumot, M.Sc,RDemail@example.com|
|Sheba Medical Center||Recruiting|
|Tel Hasomer, Israel, 52621|
|Contact: Nir Peled, MD Phd FCCP 97235307014 firstname.lastname@example.org|
|Contact: Michal Alumot, M.Sc,RD 97235307009 email@example.com|
|Sub-Investigator: Tal Frenkel, B.Sc|
|Principal Investigator:||Nir Peled, MD PhD FCCP||Sheba Medical Center|