Analysis of Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Nanostructured Sensors

Study Overview
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Brief Summary
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The aim of the study is to identify a pattern of chemoresistive sensors able to recognise the presence of a tumoral pathology from a health state through the analysis of Volatile Organic Compounds inside the specimen. The chemoresistive nanostructured sensors are into an innovative patented device SCENT B1 which can analyse different specimens: blood samples, tissue biopsies, cell cultures. In this study SCENT B1 wil be used to compare the measures of: tumoral and health tissues taken from different neoplasms after their surgical resection blood samples from healthy and tumor affected people pre and post- operative blood samples of tumor affected people

Detailed Description
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SCENT B1 is a patented device constituted by four chemoresistive nanostructured sensors able to vary their conductance depending on chemical substances present in the environment. These sensors are extremely sensitive as they can identify substances at a concentration of tens parts per billion such as volatile organic compounds derived from tumor cells metabolism. Every sensor answers differently from the others and the aim of the study is to find the best array of sensors able to discriminate among tumoral and healthy specimens. Different specimens are tested: tissue biopsies and blood samples. Blood samples are collected from patients undergoing surgical resection of the neoplasm. A first blood sample is collected before the surgery and it is compared to a control sample taken from an healthy volunteer. The second blood sample is taken from the patient during a follow-up visit after the finish of any post-operative therapy. Blood samples are conserved at ambient temperature and analyzed by SCENT B1 on the same day of the collection. Health and tumoral tissue biopsies are collected from surgical resection specimens, kept in breeding ground, cleaned from bacteria, adipose tissue and other contaminants and finally processed in SCENT B1 on the day after the collection. The four sensors' outputs are combined in statistical analysis in order to define the threshold between health and tumor affected specimens.

Official Title
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Study of the Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Sensors in Order to Identify Specific Biomarkers. Pre-clinic Evaluation

Conditions
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Tumor, Solid

Intervention / Treatment
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* Diagnostic Test: blood analysis with SCENT B1
* Diagnostic Test: tissue analysis with SCENT B1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who undergo to open or laparoscopic surgery for colorectal cancer in election regimen patients who underwent to open or laparoscopic surgery for colorectal cancer and who have finished chemotherapy or radiotherapy yet Exclusion Criteria: patients operated in emergency regimen pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tumor affected<br>Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara) | Diagnostic Test: blood analysis with SCENT B1<br>* analyze blood samples with chemoresistive sensors<br>* Other names: patent number: 102015000057717;Diagnostic Test: tissue analysis with SCENT B1<br>* analyze tumor biopsies collected during surgery with chemoresistive sensors<br>* Other names: patent number: 102015000057717;|
| Control<br>Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study | Diagnostic Test: blood analysis with SCENT B1<br>* analyze blood samples with chemoresistive sensors<br>* Other names: patent number: 102015000057717;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| capability of SCENT B1 to distinguish healthy and tumoral specimens | Analysis of the difference in voltage outputs of the array of sensors when exposed to healthy and tumoral specimens. Data are statistically combined in order to find the threshold value that distinguish healthy from tumor affected conditions | up to 3 days after surgery for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| capability of SCENT B1 to monitor cancer recurrences | comparison of SCENT B1 responses to blood samples taken from the same patient in different moments before and after surgery | during the post-treatment follow-up visit for each patient, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volatile organic compounds, colorectal cancer, non invasive diagnostic tests, medical device