Raman Analysis of Saliva as Biomarker of COPD

NCT04628962 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2022-04-04

No results posted yet for this study

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and chronic lung syndrome that causes accelerated lung function decline and death in the 20% of cases. Mostly, the non-adherence to therapy contributes to symptoms increase, mortality, inability and therapies failure, highly influencing the management costs associated to COPD. The existing procedure of diagnosing COPD is effective and fast. The acute treatment and the subsequent disease management, instead, strictly depend on the currently long and complex process of identification of three factors: COPD phenotype, adherence to chosen therapy and probability of exacerbation events. The knowledge of these factors is needed by clinicians to stratify patients and personalise the therapies and rehabilitation procedures, to initiate an effective disease management. The application of Raman spectroscopy on saliva, representing an easy collectable and highly informative biofluid, has been already proposed for different infective, neurological and cancer diseases, with promising results in the diagnostic and monitoring fields. In this project, we propose the use of Deep Learning analysis of Raman spectra collected from COPD patient's saliva to be combined with other clinical data for the development of a system able to provide fast and sensitive information regarding COPD phenotypes, adherence and exacerbation risks. This will support clinicians to personalise COPD therapies and treatments, and to monitor their effectiveness.

Conditions

Interventions

PROCEDURE

Collection and Raman analysis of saliva for the database

Saliva will be collected and processed for the Raman analysis. The collected data will be computed for the creation of the classification model

Sponsors & Collaborators

  • Geratherm Respiratory GmbH

    collaborator UNKNOWN
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER
  • Riga Stradins University

    collaborator OTHER
  • University of Milano Bicocca

    collaborator OTHER
  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Marzia Bedoni, PhD · Fondazione Don Carlo Gnocchi ONLUS, Laboratory of Nanomedicine and Clinical Biophotonics

  • Paolo I Banfo, MD · Fondazione Don Carlo Gnocchi Onlus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-11-30
Completion
2025-01-01

Countries

  • Germany
  • Italy
  • Latvia
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04628962 on ClinicalTrials.gov