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

University Hospital of Ferrara

Status: Unknown

Conditions: Tumor, Solid

Treatments: Diagnostic Test: tissue analysis with SCENT B1; Diagnostic Test: blood analysis with SCENT B1

Study type: Observational

Funder types: Other

Identifiers

NCT03929185

170484

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Tumor affected

Description:

Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)

Treatment:

Diagnostic Test: blood analysis with SCENT B1

Diagnostic Test: tissue analysis with SCENT B1

Control

Description:

Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study

Treatment:

Diagnostic Test: blood analysis with SCENT B1