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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor affected | Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara) |
| |
| Control | Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood analysis with SCENT B1 | Diagnostic Test | analyze blood samples with chemoresistive sensors |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriele Anania | Contact | 3284909378 | g.anania@unife.it |
| Name | Affiliation | Role |
|---|---|---|
| Gabriele Anania | Società Italiana Chirurgia Endoscopica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di chirurgia generale 1 | Recruiting | Ferrara | Italy |
privacy
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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whole blood and tumor biopsies
| tissue analysis with SCENT B1 | Diagnostic Test | analyze tumor biopsies collected during surgery with chemoresistive sensors |
|
|
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |