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

Tumor, Solid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929185
• Other study ID #: 170484
• Status: Recruiting
• Start date: July 13, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: University Hospital of Ferrara
• Contact: Gabriele Anania
• Phone: 3284909378
• Email: g.anania[@]unife.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Tumor, Solid

Intervention

Diagnostic Test:
• blood analysis with SCENT B1
analyze blood samples with chemoresistive sensors
• tissue analysis with SCENT B1
analyze tumor biopsies collected during surgery with chemoresistive sensors

Locations

Country	Name	City	State
Italy	Istituto di chirurgia generale 1	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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