Parkinson Disease, SecondaryNCT02588924
Study on the Relationship Between Environmental and Occupational Exposure to Metals and Parkinson's Disease
An observational study of Parkinson Disease, Secondary, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
Trial summary
The Department of Experimental Medicine - Section of Hygiene, Occupational Medicine, Forensic Medicine of the Second University of Naples, the Section of Neurology of the Second University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are involved in the realization of a research project aimed… Read more about this study
- Who is it for?
- Ages 28 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Secondary
- What is being tested?
- Second University of Naples and Neuromed IRCCS
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2015to Sep 2017
- 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 28 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases: subjects of both sexes with at least 10 years of work seniority with diagnosis of Parkinson's disease, coming from Neuromed IRCCS and Second University of Naples Controls: healthy subjects matched by age, sex, lifestyle habits and areas of residence, work seniority.
Who may be able to join
- age: subjects of working age, between 28 and 70 years;
- diagnosis of Parkinson's disease (using the criteria of the "London Brain Bank")
Who cannot join
- diseases that may interfere with toxicokinetics of the analyzed metals;
- taking medication;
- taking discretionary agents (excessive alcohol consumption);
- altered physiological states (pregnancy, strenuous physical exercise, recent meal, stress, psychological disorders);
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Second University of Naples
Naples, Napoli, 80138
Neuromed IRCCS
Pozzilli, Isernia, 86077
About this study
The Department of Experimental Medicine - Section of Hygiene, Occupational Medicine, Forensic Medicine of the Second University of Naples, the Section of Neurology of the Second University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are involved in the realization of a research project aimed at studying the correlation between environmental and occupational exposure to metals (copper, iron and manganese) and Parkinson disease in order to increase the knowledge of these possible risk factors and highlight an eventual predictive-diagnostic meaning of possible discrepancies in the content of these elements; secondly the collected data could be used for assessing the association (odd ratio-OR) between pathologies and different risk factors (for example smoking habits, professional exposure and so on).
Read the detailed description
During the selection of the sample it is essential to consider all the variables that could provoke an alteration in the levels of the indicators examined in the biological fluids investigated.
The adoption of strict criteria for inclusion and exclusion, which differ from metal to metal, is therefore necessary to establish the presence / absence of possible confounding factors that could affect the analysis or interpretation of the data.
It is to be noted also that the number of required participants in a study of MB must be sufficiently large to allow an adequate statistical analysis: the more limited the group of subjects included in the study is, the broader the variability of the data due to inter-individual and methodological differences.
In light of this, some variables, such as age and sex, will be firstly neglected and other potential confounding factors will be considered such as, for example, smoking habits.
Based on the purpose of the research project, the following criteria for exclusion will be considered:
- diseases that may interfere with toxicokinetics of the analyzed metals;
- pharmacological therapy;
- habit-forming additives consumption (excessive alcohol consumption);
- altered physiological states (pregnancy, strenuous physical exercise, recent meal, stress, psychological disorders);
On the contrary, the basic criteria for inclusion in the study are:
- age: subjects of working age, between 18 and 65 years;
- diagnosis of Parkinson's disease (using the criteria of the "London Brain Bank")
Regarding the criteria of partition or stratification of the subjects, the type and number of the possible partitions are conditioned by the sample size; indeed it is essential to ensure a sufficient number of cases (and if possible a similar number of cases) in the various layers to have correct statistical results. It was recommended that the minimum number of subjects per layer must be equal to 80.
In order to collect all the necessary information for the inclusion of subjects in the study and the subsequent stratification of the data, an anonymous questionnaire was realized and administered to each recruited subject.
The questionnaire deals with the environment and the lifestyle and work habits of every participant and it consists of multiple choice questions and free response questions and is divided into macro areas: identification data for data processing; place of residence; professional activity; extraprofessional activities; eating habits; habit-forming additives consumption; medical history.
Each question will be transformed into a "continue" or "categorical" variable in order to be able to build and constantly update a database summarizing the collected data and allowing the statistical analysis of the results.
Each subject enrolled will be also asked to sign a consent form, which states that he or she voluntarily take part to the study, after being informed about the purpose of the study and the analysis of both biological samples and personal data.
The guarantee of anonymity for people recruited for this study is provided by an anonymous questionnaire which do not contain personal data, which are collected only in the consent form, separately from the questionnaire.
- Conditions
- Parkinson Disease, Secondary
- Being tested
- Second University of Naples, Neuromed IRCCS
- Keywords
- Parkinson Disease, ENVIRONMENTAL AND OCCUPATIONAL EXPOSURE TO METALS
- Medical subject headings
- Parkinson Disease, Secondary, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second University of NaplesOther
enrollment of patients with Parkinson's disease; collection of blood samples; measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology.
Neuromed IRCCSOther
enrollment of patients with Parkinson's disease; collection of blood samples;
| Study group | Role | What they receive |
|---|---|---|
| Second University of Naples | the present research project is aimed at measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology. Receives: Other: Second University of Naples | |
| Neuromed IRCCS | the present research project is aimed at measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology. Receives: Other: Neuromed IRCCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Enrollment: In order to verify if some factors might be connected with a metals exposure for the disease onset, a questionnaire investigating the patients' residence area, the field of work and the specific activities carried out, as well as lifestyle habits has been prepared.
Sample Collection: Patients and controls will be subject to blood sampling for manganese, copper and iron quantitative analysis
Measured: two-year
Sample Collection
We sample 5 ml of blood in tube serum (at least 2 ml of serum) then we label the test tube with an identifying code which is: S-PRK(for cases affected by Parkinson followed by a progressive number es. S-PRK 1,2,3…..), and S-CRL (for controls followed by a progressive number es. S-CRL 1,2,3….)
This samples will be centrifugated at 4000 rpm for 10 min. Than we divide the serum in 5 eppendorf of 1.5 mL for cases and 5 for controls:
- Eppendorf 1: 300 µl of serum labeled AMN-X (X indicating the progressive number both for cases and controls)
- Eppendorf 2: 300 µl of serum labeled BMN-X
- Eppendorf 3: 300 µl of serum labeled ACU-X
- Eppendorf 4: 300 µl of serum labeled BCU-X
- Eppendorf 5: the remaining serum put in Fe-X
The aliquots will be stored in a refrigerator at 4-6 ° C (no longer than 7 days) in appropriate Eppendorf box, in order to avoid the inclination of the sample with consequent loss of serum.
Measured: two-year
Secondary outcomes (1)
determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron
the determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron on the eppendorf sampled will be carried out at the Laboratory of Industrial Toxicology of Occupational Medicine Area - Section of Hygiene, Occupational Medicine, Forensic Medicine of the Second University of Naples
Measured: two-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, SecondaryStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Neuromed IRCCS
- Responsible party
- Principal investigator, PAOLA PEDATA, University of Campania Luigi Vanvitelli
- Investigators
- Paola Pedata, researcher, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588924
- Sponsor's protocol ID
- 961
- Status last verified
- Oct 2015
- First submitted
- 28 Sep 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Environmental and Occupational Exposure to Metals and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02588924
- Acronym / sponsor ID
- 961
- Conditions
- Parkinson Disease, Secondary
- Keywords
- Parkinson Disease, ENVIRONMENTAL AND OCCUPATIONAL EXPOSURE TO METALS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Neuromed IRCCS
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- 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 Department of Experimental Medicine - Section of Hygiene, Occupational Medicine, Forensic Medicine of the Second University of Naples, the Section of Neurology of the Second University of Naples and the Mediterranean Neurological Institute NEUROMED, IRCCS are involved in the realization of a research project aimed at studying the correlation between environmental and occupational exposure to metals (copper, iron and manganese) and Parkinson disease in order to increase the knowledge of these possible risk factors and highlight an eventual predictive-diagnostic meaning of possible discrepancies in the content of these elements; secondly the collected data could be used for assessing the association (odd ratio-OR) between pathologies and different risk factors (for example smoking habits, professional exposure and so on).
Detailed description
During the selection of the sample it is essential to consider all the variables that could provoke an alteration in the levels of the indicators examined in the biological fluids investigated.
The adoption of strict criteria for inclusion and exclusion, which differ from metal to metal, is therefore necessary to establish the presence / absence of possible confounding factors that could affect the analysis or interpretation of the data.
It is to be noted also that the number of required participants in a study of MB must be sufficiently large to allow an adequate statistical analysis: the more limited the group of subjects included in the study is, the broader the variability of the data due to inter-individual and methodological differences.
In light of this, some variables, such as age and sex, will be firstly neglected and other potential confounding factors will be considered such as, for example, smoking habits.
Based on the purpose of the research project, the following criteria for exclusion will be considered:
- diseases that may interfere with toxicokinetics of the analyzed metals;
- pharmacological therapy;
- habit-forming additives consumption (excessive alcohol consumption);
- altered physiological states (pregnancy, strenuous physical exercise, recent meal, stress, psychological disorders);
On the contrary, the basic criteria for inclusion in the study are:
- age: subjects of working age, between 18 and 65 years;
- diagnosis of Parkinson's disease (using the criteria of the "London Brain Bank")
Regarding the criteria of partition or stratification of the subjects, the type and number of the possible partitions are conditioned by the sample size; indeed it is essential to ensure a sufficient number of cases (and if possible a similar number of cases) in the various layers to have correct statistical results. It was recommended that the minimum number of subjects per layer must be equal to 80.
In order to collect all the necessary information for the inclusion of subjects in the study and the subsequent stratification of the data, an anonymous questionnaire was realized and administered to each recruited subject.
The questionnaire deals with the environment and the lifestyle and work habits of every participant and it consists of multiple choice questions and free response questions and is divided into macro areas: identification data for data processing; place of residence; professional activity; extraprofessional activities; eating habits; habit-forming additives consumption; medical history.
Each question will be transformed into a "continue" or "categorical" variable in order to be able to build and constantly update a database summarizing the collected data and allowing the statistical analysis of the results.
Each subject enrolled will be also asked to sign a consent form, which states that he or she voluntarily take part to the study, after being informed about the purpose of the study and the analysis of both biological samples and personal data.
The guarantee of anonymity for people recruited for this study is provided by an anonymous questionnaire which do not contain personal data, which are collected only in the consent form, separately from the questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second University of Naples | – | Other: Second University of Naplesthe present research project is aimed at measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology. |
| Neuromed IRCCS | – | Other: Neuromed IRCCSthe present research project is aimed at measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology. |
Who may qualify
- Ages
- 28 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: subjects of both sexes with at least 10 years of work seniority with diagnosis of Parkinson's disease, coming from Neuromed IRCCS and Second University of Naples Controls: healthy subjects matched by age, sex, lifestyle habits and areas of residence, work seniority.
Key inclusion criteria (2 listed)
- age: subjects of working age, between 28 and 70 years;
- diagnosis of Parkinson's disease (using the criteria of the "London Brain Bank")
Key exclusion criteria (4 listed)
- diseases that may interfere with toxicokinetics of the analyzed metals;
- taking medication;
- taking discretionary agents (excessive alcohol consumption);
- altered physiological states (pregnancy, strenuous physical exercise, recent meal, stress, psychological disorders);
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 |
|---|---|---|
| Second University of Naplesenrollment of patients with Parkinson's disease; collection of blood samples; measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology. | Other | Second University of Naples |
| Neuromed IRCCSenrollment of patients with Parkinson's disease; collection of blood samples; | Other | Neuromed IRCCS |
Primary outcome
Enrollment
Time frame: two-year
Enrollment: In order to verify if some factors might be connected with a metals exposure for the disease onset, a questionnaire investigating the patients' residence area, the field of work and the specific activities carried out, as well as lifestyle habits has been prepared. Sample Collection: Patients and controls will be subject to blood sampling for manganese, copper and iron quantitative analysis
Sample Collection
Time frame: two-year
We sample 5 ml of blood in tube serum (at least 2 ml of serum) then we label the test tube with an identifying code which is: S-PRK(for cases affected by Parkinson followed by a progressive number es. S-PRK 1,2,3…..), and S-CRL (for controls followed by a progressive number es. S-CRL 1,2,3….) This samples will be centrifugated at 4000 rpm for 10 min. Than we divide the serum in 5 eppendorf of 1.5 mL for cases and 5 for controls: * Eppendorf 1: 300 µl of serum labeled AMN-X (X indicating the progressive number both for cases and controls) * Eppendorf 2: 300 µl of serum labeled BMN-X * Eppendorf 3: 300 µl of serum labeled ACU-X * Eppendorf 4: 300 µl of serum labeled BCU-X * Eppendorf 5: the remaining serum put in Fe-X The aliquots will be stored in a refrigerator at 4-6 ° C (no longer than 7 days) in appropriate Eppendorf box, in order to avoid the inclination of the sample with consequent loss of serum.
1 secondary outcome
determination by atomic absorption spectroscopy of the concentration of manganese, copper and iron
Time frame: two-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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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.
Paola Pedata, researcher principal investigator
University of Campania Luigi Vanvitelli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, Secondary, run by University of Campania Luigi Vanvitelli at 2 sites 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 4 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: two-year). The study lists 2 primary outcomes in all. 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 28 Oct 2015.