Study of the Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Sensors in Order to Identify Specific Biomarkers. Pre-clinic Evaluation
Sponsor study identifier
observational
100
1 country
1
Study Start
July 13, 2017
Actual (reported)Primary Completion
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2017
Actual (reported)April 17, 2019
Actual (reported)April 26, 2019
Actual (reported)December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
up to 3 days after surgery for each patient
capability of SCENT B1 to monitor cancer recurrences
during the post-treatment follow-up visit for each patient, an average of 1 year
Patients affected by colorectal cancer who underwent to surgical resection in Sant'Anna Hospital in Cona (Ferrara)
Healthy people aged 20-35 years old without risk factors for colorectal cancers who voluntarily participated to the study
analyze blood samples with chemoresistive sensors
analyze tumor biopsies collected during surgery with chemoresistive sensors
People coming to Sant'Anna University Hospital of Cona, Ferrara (Italy)
Istituto di chirurgia generale 1
Ferrara, Italy
whole blood and tumor biopsies
Gabriele Anania
Società Italiana Chirurgia Endoscopica
First Submitted
April 17, 2019
First Posted
April 26, 2019
Study Start
July 13, 2017
Actual (reported)Primary Completion
December 1, 2022
Estimated (date passed)BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 1, 2021
Record last verified: 2021-09
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