Tumor, SolidNCT03929185
Analysis of Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Nanostructured Sensors
An observational study of Tumor, Solid, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- blood analysis with SCENT B1 and tissue analysis with SCENT B1
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jul 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)
Who may be able to join
- 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
Who cannot join
- patients operated in emergency regimen
- pregnant women
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto di chirurgia generale 1
Ferrara
Gabriele Anania, 3284909378, g.anania@unife.it
Giorgio Rispoli
About this study
Official title: Study of the Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Sensors in Order to Identify Specific Biomarkers. Pre-clinic Evaluation
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
Read the 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.
- Conditions
- Tumor, Solid
- Being tested
- blood analysis with SCENT B1, tissue analysis with SCENT B1
- Keywords
- Volatile organic compounds, colorectal cancer, non invasive diagnostic tests, medical device
- Medical subject headings
- Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood analysis with SCENT B1Diagnostic test
Also called patent number: 102015000057717
analyze blood samples with chemoresistive sensors
tissue analysis with SCENT B1Diagnostic test
Also called patent number: 102015000057717
analyze tumor biopsies collected during surgery with chemoresistive sensors
| Study group | Role | What they receive |
|---|---|---|
| Tumor affected | Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara) Receives: 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 Receives: Diagnostic Test: blood analysis with SCENT B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
capability of SCENT B1 to distinguish healthy and tumoral specimens
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
Measured: up to 3 days after surgery for each patient
Secondary outcomes (1)
capability of SCENT B1 to monitor cancer recurrences
comparison of SCENT B1 responses to blood samples taken from the same patient in different moments before and after surgery
Measured: during the post-treatment follow-up visit for each patient, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start13 Jul 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Anania, University Hospital of Ferrara
- Investigators
- Gabriele Anania, Principal investigator, Società Italiana Chirurgia Endoscopica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929185
- Sponsor's protocol ID
- 170484
- Status last verified
- Sep 2021
- First submitted
- 17 Apr 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: privacy
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Sensors in Order to Identify Specific Biomarkers. Pre-clinic Evaluation
- ClinicalTrials.gov ID
- NCT03929185
- Acronym / sponsor ID
- 170484
- Conditions
- Tumor, Solid
- Keywords
- Volatile organic compounds, colorectal cancer, non invasive diagnostic tests, medical device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor affected | – | Diagnostic Test: blood analysis with SCENT B1, Diagnostic Test: tissue analysis with SCENT B1Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara) |
| Control | – | Diagnostic Test: blood analysis with SCENT B1Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients operated in emergency regimen
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood analysis with SCENT B1Also: patent number: 102015000057717analyze blood samples with chemoresistive sensors | Diagnostic test | Control, Tumor affected |
| tissue analysis with SCENT B1Also: patent number: 102015000057717analyze tumor biopsies collected during surgery with chemoresistive sensors | Diagnostic test | Tumor affected |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No. privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Anania principal investigator
Società Italiana Chirurgia Endoscopica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor, Solid, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Anania (3284909378, g.anania@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
capability of SCENT B1 to distinguish healthy and tumoral specimens (time frame: up to 3 days after surgery for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.