Tumor, Solid
Conditions
Keywords
Volatile organic compounds, colorectal cancer, non invasive diagnostic tests, medical device
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTblood analysis with SCENT B1
analyze blood samples with chemoresistive sensors
DIAGNOSTIC_TESTtissue analysis with SCENT B1
analyze tumor biopsies collected during surgery with chemoresistive sensors
Sponsors
University Hospital of Ferrara
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| capability of SCENT B1 to distinguish healthy and tumoral specimens | up to 3 days after surgery for each patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| capability of SCENT B1 to monitor cancer recurrences | during the post-treatment follow-up visit for each patient, an average of 1 year | comparison of SCENT B1 responses to blood samples taken from the same patient in different moments before and after surgery |
Countries
Italy
Contacts
Primary ContactGabriele Anania
Outcome results
None listed