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

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ClinicalTrials.gov Identifier: NCT03929185
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriele Anania, 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

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.


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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 : July 1, 2019
Estimated Study Completion Date : December 31, 2020

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




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929185


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

Locations
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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
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Principal Investigator: Gabriele Anania Società Italiana Chirurgia Endoscopica

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Responsible Party: Gabriele Anania, Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03929185     History of Changes
Other Study ID Numbers: 170484
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: privacy

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriele Anania, University Hospital of Ferrara:
Volatile organic compounds
colorectal cancer
non invasive diagnostic tests
medical device

Additional relevant MeSH terms:
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Neoplasms