Analysis of Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Nanostructured Sensors
NCT ID: NCT03929185
Last Updated: 2021-10-01
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2017-07-13
2022-12-31
Brief Summary
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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
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Detailed Description
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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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Study Design
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CASE_CONTROL
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
analyze blood samples with chemoresistive sensors
tissue analysis with SCENT B1
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
analyze blood samples with chemoresistive sensors
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who underwent to open or laparoscopic surgery for colorectal cancer and who have finished chemotherapy or radiotherapy yet
Exclusion Criteria
* pregnant women
18 Years
ALL
Yes
Sponsors
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University Hospital of Ferrara
OTHER
Responsible Party
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Gabriele Anania
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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170484
Identifier Type: -
Identifier Source: org_study_id
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