Clinical trial NCT03929185: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor, Solid
Keywords: Volatile organic compounds
colorectal cancer
non invasive diagnostic tests
medical device
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)

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.

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

Primary outcomes:
measure: capability of SCENT B1 to distinguish healthy and tumoral specimens
timeFrame: up to 3 days after surgery for each patient
Secondary outcomes:
measure: capability of SCENT B1 to monitor cancer recurrences
timeFrame: during the post-treatment follow-up visit for each patient, an average of 1 year
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Istituto di chirurgia generale 1
Study officials:
affiliation: Società Italiana Chirurgia Endoscopica
name: Gabriele Anania
role: PRINCIPAL_INVESTIGATOR
References: