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出境医 / 临床实验 / Analysis of Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Nanostructured Sensors

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

Study Description
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

Condition or disease Intervention/treatment
Tumor, Solid Diagnostic Test: blood analysis with SCENT B1 Diagnostic Test: tissue analysis with SCENT B1

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of the Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Sensors in Order to Identify Specific Biomarkers. Pre-clinic Evaluation
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021
Arms 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 Name: patent number: 102015000057717

Diagnostic Test: tissue analysis with SCENT B1
analyze tumor biopsies collected during surgery with chemoresistive sensors
Other Name: 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 Name: patent number: 102015000057717
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
whole blood and tumor biopsies

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)
Criteria

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
Contacts and Locations

Contacts
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Contact: Gabriele Anania 3284909378 g.anania@unife.it

Locations
Layout table for location information
Italy
Istituto di chirurgia generale 1 Recruiting
Ferrara, Italy
Contact: Gabriele Anania    3284909378    g.anania@unife.it   
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         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
Layout table for investigator information
Principal Investigator: Gabriele Anania Società Italiana Chirurgia Endoscopica
Tracking Information
First Submitted Date April 17, 2019
First Posted Date April 26, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date July 13, 2017
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2019) 		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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Nanostructured Sensors
Official Title Study of the Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Sensors in Order to Identify Specific Biomarkers. Pre-clinic Evaluation
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood and tumor biopsies
Sampling Method Non-Probability Sample
Study Population People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)
Condition Tumor, Solid
Intervention
  • Diagnostic Test: blood analysis with SCENT B1
    analyze blood samples with chemoresistive sensors
    Other Name: patent number: 102015000057717
  • Diagnostic Test: tissue analysis with SCENT B1
    analyze tumor biopsies collected during surgery with chemoresistive sensors
    Other Name: patent number: 102015000057717
Study Groups/Cohorts
  • Tumor affected
    Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)
    Interventions:
    • Diagnostic Test: blood analysis with SCENT B1
    • Diagnostic Test: tissue analysis with SCENT B1
  • Control
    Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study
    Intervention: Diagnostic Test: blood analysis with SCENT B1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2019) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Gabriele Anania 3284909378 g.anania@unife.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03929185
Other Study ID Numbers 170484
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: privacy
Responsible Party Gabriele Anania, University Hospital of Ferrara
Study Sponsor University Hospital of Ferrara
Collaborators Not Provided
Investigators
Principal Investigator: Gabriele Anania Società Italiana Chirurgia Endoscopica
PRS Account University Hospital of Ferrara
Verification Date November 2020

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