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

NCT ID: NCT03929185

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-13

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Tumor, Solid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Tumor affected

Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)

blood analysis with SCENT B1

Intervention Type DIAGNOSTIC_TEST

analyze blood samples with chemoresistive sensors

tissue analysis with SCENT B1

Intervention Type DIAGNOSTIC_TEST

analyze tumor biopsies collected during surgery with chemoresistive sensors

Control

Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study

blood analysis with SCENT B1

Intervention Type DIAGNOSTIC_TEST

analyze blood samples with chemoresistive sensors

Interventions

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blood analysis with SCENT B1

analyze blood samples with chemoresistive sensors

Intervention Type DIAGNOSTIC_TEST

tissue analysis with SCENT B1

analyze tumor biopsies collected during surgery with chemoresistive sensors

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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patent number: 102015000057717 patent number: 102015000057717

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Anania

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriele Anania

Role: PRINCIPAL_INVESTIGATOR

Società Italiana Chirurgia Endoscopica

Locations

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Istituto di chirurgia generale 1

Ferrara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gabriele Anania

Role: CONTACT

3284909378

Facility Contacts

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Gabriele Anania

Role: primary

3284909378

Other Identifiers

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170484

Identifier Type: -

Identifier Source: org_study_id

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