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

September 29, 2021 updated by: Gabriele Anania, University Hospital of Ferrara

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ferrara, Italy
        • Recruiting
        • Istituto di chirurgia generale 1
        • Contact:
        • Principal Investigator:
          • Giorgio Rispoli
        • Principal Investigator:
          • Paola Secchiero
        • Sub-Investigator:
          • Giovanni Lanza
        • Sub-Investigator:
          • Stefania Gallo
        • Sub-Investigator:
          • Veronica Tisato
        • Sub-Investigator:
          • Mascia Benedusi
        • Sub-Investigator:
          • Michele Astolfi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tumor affected
Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)
Diagnostic test: blood analysis with SCENT B1
analyze blood samples with chemoresistive sensors
Other Names:
  • patent number: 102015000057717
Diagnostic test: tissue analysis with SCENT B1
analyze tumor biopsies collected during surgery with chemoresistive sensors
Other Names:
  • patent number: 102015000057717
Control
Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study
Diagnostic test: blood analysis with SCENT B1
analyze blood samples with chemoresistive sensors
Other Names:
  • patent number: 102015000057717

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
capability of SCENT B1 to distinguish healthy and tumoral specimens
Time Frame: 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
up to 3 days after surgery for each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
capability of SCENT B1 to monitor cancer recurrences
Time Frame: 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
during the post-treatment follow-up visit for each patient, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2017

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (ACTUAL)

April 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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