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

• Conditions: Tumor, Solid
• Interventions: Diagnostic Test: blood analysis with SCENT B1; Diagnostic Test: tissue analysis with SCENT B1

• Registration Number: NCT03929185
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumor affected	tissue analysis with SCENT B1	Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)
Control	blood analysis with SCENT B1	Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study
Tumor affected	blood analysis with SCENT B1	Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto di chirurgia generale 1; 🇮🇹 Ferrara, Italy