A Phase I Study of iPS Cell Generation From Patients With COPD
NCT01860898
Bronchial Neoplasms, COPD
Rochester, Minnesota, United States
View Trial DetailsNCT Number: NCT06800586
This study aims to examine the exposure to atmospheric pollutants in a group of non-smoking patients suffering from lung cancer, chronic obstructive pulmonary disease (COPD), and leukemia. The exposure to atmospheric pollutants will be assessed simultaneously in a group of healthy volunteers. The ultimate goal of the study is to enhance the understanding of the mechanisms by which atmospheric pollutants act, in order to develop new tools that can help halt or at least delay the development of diseases associated with pollution.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
Atmospheric pollution represents a global issue today. A significant portion of the population in Italy lives in areas where air quality standards are very low, both due to global warming and human-caused pollution. This not only poses a serious risk to human health but also has a tremendous economic and social impact on the National Health System. Atmospheric pollution is associated with a variety of diseases affecting nearly all organs and systems.
In almost all currently available studies on atmospheric pollution and its effects on humans, the population's exposure to pollutants is not measured at the individual level; instead, it is estimated using various environmental sampling techniques based on geographical areas and then applied to individuals based on their residence. There is also a lack of information regarding the effects of confounding risk factors, especially concerning cigarette smoking.
This study aims to acquire more information on the individual exposure to pollutants in a group of non-smoking patients suffering from lung cancer, COPD, and leukemia. The decision to evaluate only never-smokers ensures that there are no confounding factors in the association study between health and environmental pollution.
During a scheduled visit at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna, the Department of Medical Oncology, IRCCS AOU of Bologna, and the Department of Hematology, Hospital-University Company, Policlinico Riuniti di Foggia, and after obtaining informed consent, the following biological samples will be collected in a non-invasive manner and in small aliquots: exhalate, respiratory condensate, sputum, blood, and urine. The collected samples will then be analyzed by the laboratories of the Occupational Medicine Department (IRCCS - AOU of Bologna) and the Messina Institute of Technology (MeIT) of the Department of Chemical, Biological, Pharmaceutical, and Environmental Sciences (CHIBIOFARAM) of the University of Messina using advanced techniques such as electron microscopy, mass spectrometry chromatography, and for the determination of pollutants such as particulate matter and volatile compounds. Furthermore, the project also aims to identify effect biomarkers involved in the response to such agents.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Healthy Volunteer Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Exclusion criteria
Patient Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Pneumology and Respiratory Intensive Care, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Healthy Volunteer Cohort to be Recruited at the Department of Medical Oncology, IRCCS AOU of Bologna:
Patient Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Healthy Volunteer Cohort to be Recruited at the Hematology Department (Hospital-University Company, Policlinico Riuniti di Foggia):
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Scanning Electron Microscopy (SEM): presence of inorganic and organic particulate matter
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Transmission Electron Microscopy (TEM): presence of inorganic and organic particulate matter
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Atomic Force Microscopy (AFM): presence of inorganic and organic particulate matter
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Infrared (IR) and Raman Spectroscopy: presence of inorganic and organic particulate matter
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Inductively Coupled Plasma Mass Spectrometry (ICP-MS): presence of metals
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months."
-Gas Chromatography-Mass Spectrometry (GC-MS): presence of volatile compounds (e.g., VOCs) and semi-volatile compounds
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months.
The objective will be measured by comparing the concentration (units/volume) of the identified pollutants within the biological samples of patients affected by lung cancer, COPD, and leukemia with those identified in the biological samples of healthy subjects, collected through:
Time frame: The collection of biological samples will be conducted during the enrollment visit, and the analyses will be carried out over the following 18 months
The objective will be measured by evaluating the alteration of endogenous molecule content (biomarkers) in the presence of the identified pollutants through the conduction of dose-response curves.
High-Performance Liquid Chromatography/Mass Spectrometry (HPLC-MS) Gas Chromatography-Mass Spectrometry (GC-MS)
Contact information is provided by the study sponsor or research team.
Francesco Saverio Violante, MD
CONTACT
Stefano Nava, MD
CONTACT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Acronym: RECAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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