Beta-thalassemiaPEACHNCT06512298
Plasticizer Exposure and Its Consequences on Health
An observational study of Beta-thalassemia and Glioma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Plasticizers are chemicals commonly found in many everyday items, from food packaging to medical equipment. Although they are pervasive in our daily lives, researchers still don't have a clear picture of their long-term effects on human health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Beta-thalassemia, Glioma, Healthy Controls
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Two study cohorts will be recruited, one to study chronic exposure to plasticizers and another to analyze the "acute" penetration of plasticizers into the central nervous system. In total, 20 TDTM patients, 20 non-transfusion-dependent ß-thalassemia intermedia/minor patients, and 20 healthy controls will be recruited to study chronic exposure. To study the pharmacokinetics of acute transfusion-related accumulation of plasticizers within the CNS, 20 patients undergoing glioma resection, 20 ICU patients suffering from brain hemorrhage without ventricular collapse, and CSF from a cohort of medical-plastic-naïve patients undergoing diagnostic lumbar puncture in the outpatient setting (n=20) will be recruited.
Who may be able to join
- Exclusion: Chronic disease, plastic implants, infectious disease, pregnancy, anemia, medication-, drug-, or alcohol-abuse
- Glioma patients:
- Inclusion: Adult, high/low-grade glioma, tumor larger then 3cm, resection with access to the ventricular system
- Exclusion: Large intraventricular hemorrhage, plastic implants, infectious disease
- ICU patients:
- Inclusion: Adult, brain hemorrhage, external CSF drain from ventricle
Show all 10Show fewer
- Exclusion: intraventricular hemorrhage, plastic implants, ECMO, hemodialysis, infectious disease
- Patients undergoing diagnostic lumbar-puncture:
- Inclusion: Adult, diagnostic CSF sampling, outpatient setting
- Exclusion: Ventricular hemorrhage, plastic implants, infectious disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna
Vienna, 1090
Lukas Wisgrill, MD, PhD, lukas.wisgrill@meduniwien.ac.at
Michael Eigenschink, MD, 0043-1-40400-38485, michael.eigenschink@meduniwien.ac.at
About this study
Plasticizers are chemicals commonly found in many everyday items, from food packaging to medical equipment. Although they are pervasive in our daily lives, researchers still don't have a clear picture of their long-term effects on human health. Evidence suggests that these substances might disrupt various biological functions such as the immune system, the balance of gut bacteria, hormone regulation, and brain processes. While some studies have linked plasticizer exposure to health issues, definitive data from human studies are still lacking.
The PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health. The study focuses on understanding how these chemicals are absorbed, distributed, and accumulated in the body across different groups of patients. The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells, as well as their effects on neurotransmitters involved in brain function.
Read more
A combination of patient data, systems biology, and laboratory models will be used to thoroughly assess the biological impacts of plasticizers. Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties, sequencing technologies will be used to examine immune effects, and radiouptake assays will be employed to explore interactions with neurotransmitter transport. This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers.
The PEACH study introduces innovative methods to the field, aiming to create a robust model for understanding how plasticizer compounds behave in the human body. It employs state-of-the-art techniques to assess the dynamics of these chemicals, marking a significant advancement in environmental health research.
Read the detailed description
Wider research context: Industrial plasticizers are ubiquitous in modern society, utilized in products ranging from food packaging to medical supplies. Despite their widespread use, the health implications of chronic plasticizer exposure in humans remain inadequately understood. These substances potentially interfere and disrupt various biological processes, including immune activity, gut microbiota balance, endocrinological function, and neurophysiological health. Current epidemiological or exposure studies were able to pinpoint clinical associations with plasticizer exposures, but conclusive mechanistic human in vivo data are missing.
Research questions: The PEACH study is designed to fill critical gaps in the understanding of the biological implications of plasticizer exposure. The investigators aim to analyse the pharmacokinetics of plasticizers in different patient cohorts and elucidate their bioaccumulation, distribution, and metabolism. Thereby, the interplay between plasticizer exposure and metabolism, gut microbiota composition and immune cell functionality will be explored. Furthermore, the impact of plasticizer exposure on neurotransmitter physiology will be elucidated.
Approach: The study employs a comprehensive methodology that integrates the findings from clinical cohorts, systems biology approaches, and in vitro models. Three distinct work packages will examine pharmacokinetic properties via mass spectrometry, study immunological effects through advanced sequencing technologies \& phenotypization, and investigate pharmacodynamic interactions with neurotransmitter transporters using human in-vitro assays. Longitudinal sampling from acute and chronic exposure cohorts will offer an evolving perspective on effects of plasticizer exposure.
Level of originality: The PEACH study introduces groundbreaking methodologies and scope to the investigation of plasticizer exposure. It aims to support the scientific community with first human in-vivo pharmacokinetic models for these compounds while utilizing high-throughput techniques for pharmacodynamic assessment, marking a notable advancement in the field.
- Conditions
- Beta-thalassemia, Glioma, Healthy Controls, Transfusion-dependent Beta-Thalassemia, Intracranial Hemorrhages, Toxicity
- Keywords
- Plasticizer, Transfusion, Systems Biology, Immunology, Microbiome, Neuropharmacology, Pharmacokinetics, Pharmacodynamics, Exposomics
- Medical subject headings
- beta-Thalassemia, Glioma, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion-dependent thalassemia major (TDTM) | Patients suffering from homozygous transfusion-dependent Thalassemia Major. | |
| Thalassemia Minor | Patients suffering from heterozygous transfusion-independent Thalassemia Minor. | |
| Healthy controls | Healthy adult controls without any prevalent substance use (nicotine, alcohol etc.). | |
| Glioma patients | Adults with high/low-grade glioma, a tumor size > 3cm that require resection with access to the ventricular system without ventricular hemorrhage. | |
| ICU patients | Adults with brain hemorrhage (intracranial, subdural, subarachnoidal), treated with a ventricular shunt. | |
| Patients undergoing diagnostic lumbar-puncture (plastic-naive) | Adults that receive a diagnostic lumbar puncture in an outpatient setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of plasticizers in transfused patients
Plasticizer concentrations (mmol/L) will be measured from the plasma of thalassemia major patients two weeks after the last pRBC-transfusion and compared to plasma levels of healthy controls of beta-thalassemia intermedia/minor patient using MANCOVA. Age, sex and liver/kidney retention will be taken into account as covariates and Tukey HSD or Scheffe tests used for even and uneven group sizes, respectively.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-thalassemiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Principal investigator, Lukas Wisgrill, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512298
- Sponsor's protocol ID
- 1716/2023
- Other IDs
- 10.55776/KLP1811624
- Acronym
- PEACH
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticizer Exposure and Its Consequences on Health
- ClinicalTrials.gov ID
- NCT06512298
- Acronym / sponsor ID
- PEACH / 1716/2023
- Conditions
- Beta-thalassemia, Glioma, Healthy Controls, Transfusion-dependent Beta-Thalassemia, Intracranial Hemorrhages, Toxicity
- Keywords
- Plasticizer, Transfusion, Systems Biology, Immunology, Microbiome, Neuropharmacology, Pharmacokinetics, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Jul 2024 (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.
Plasticizers are chemicals commonly found in many everyday items, from food packaging to medical equipment. Although they are pervasive in our daily lives, researchers still don't have a clear picture of their long-term effects on human health. Evidence suggests that these substances might disrupt various biological functions such as the immune system, the balance of gut bacteria, hormone regulation, and brain processes. While some studies have linked plasticizer exposure to health issues, definitive data from human studies are still lacking.
The PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health. The study focuses on understanding how these chemicals are absorbed, distributed, and accumulated in the body across different groups of patients. The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells, as well as their effects on neurotransmitters involved in brain function.
A combination of patient data, systems biology, and laboratory models will be used to thoroughly assess the biological impacts of plasticizers. Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties, sequencing technologies will be used to examine immune effects, and radiouptake assays will be employed to explore interactions with neurotransmitter transport. This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers.
The PEACH study introduces innovative methods to the field, aiming to create a robust model for understanding how plasticizer compounds behave in the human body. It employs state-of-the-art techniques to assess the dynamics of these chemicals, marking a significant advancement in environmental health research.
Detailed description
Wider research context: Industrial plasticizers are ubiquitous in modern society, utilized in products ranging from food packaging to medical supplies. Despite their widespread use, the health implications of chronic plasticizer exposure in humans remain inadequately understood. These substances potentially interfere and disrupt various biological processes, including immune activity, gut microbiota balance, endocrinological function, and neurophysiological health. Current epidemiological or exposure studies were able to pinpoint clinical associations with plasticizer exposures, but conclusive mechanistic human in vivo data are missing.
Research questions: The PEACH study is designed to fill critical gaps in the understanding of the biological implications of plasticizer exposure. The investigators aim to analyse the pharmacokinetics of plasticizers in different patient cohorts and elucidate their bioaccumulation, distribution, and metabolism. Thereby, the interplay between plasticizer exposure and metabolism, gut microbiota composition and immune cell functionality will be explored. Furthermore, the impact of plasticizer exposure on neurotransmitter physiology will be elucidated.
Approach: The study employs a comprehensive methodology that integrates the findings from clinical cohorts, systems biology approaches, and in vitro models. Three distinct work packages will examine pharmacokinetic properties via mass spectrometry, study immunological effects through advanced sequencing technologies \& phenotypization, and investigate pharmacodynamic interactions with neurotransmitter transporters using human in-vitro assays. Longitudinal sampling from acute and chronic exposure cohorts will offer an evolving perspective on effects of plasticizer exposure.
Level of originality: The PEACH study introduces groundbreaking methodologies and scope to the investigation of plasticizer exposure. It aims to support the scientific community with first human in-vivo pharmacokinetic models for these compounds while utilizing high-throughput techniques for pharmacodynamic assessment, marking a notable advancement in the field.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Transfusion-dependent thalassemia major (TDTM) | – | –Patients suffering from homozygous transfusion-dependent Thalassemia Major. |
| Thalassemia Minor | – | –Patients suffering from heterozygous transfusion-independent Thalassemia Minor. |
| Healthy controls | – | –Healthy adult controls without any prevalent substance use (nicotine, alcohol etc.). |
| Glioma patients | – | –Adults with high/low-grade glioma, a tumor size > 3cm that require resection with access to the ventricular system without ventricular hemorrhage. |
| ICU patients | – | –Adults with brain hemorrhage (intracranial, subdural, subarachnoidal), treated with a ventricular shunt. |
| Patients undergoing diagnostic lumbar-puncture (plastic-naive) | – | –Adults that receive a diagnostic lumbar puncture in an outpatient setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two study cohorts will be recruited, one to study chronic exposure to plasticizers and another to analyze the "acute" penetration of plasticizers into the central nervous system. In total, 20 TDTM patients, 20 non-transfusion-dependent ß-thalassemia intermedia/minor patients, and 20 healthy controls will be recruited to study chronic exposure. To study the pharmacokinetics of acute transfusion-related accumulation of plasticizers within the CNS, 20 patients undergoing glioma resection, 20 ICU patients suffering from brain hemorrhage without ventricular collapse, and CSF from a cohort of medical-plastic-naïve patients undergoing diagnostic lumbar puncture in the outpatient setting (n=20) will be recruited.
Key inclusion criteria (10 listed)
- Exclusion: Chronic disease, plastic implants, infectious disease, pregnancy, anemia, medication-, drug-, or alcohol-abuse
- Inclusion: Adult, high/low-grade glioma, tumor larger then 3cm, resection with access to the ventricular system
- Exclusion: Large intraventricular hemorrhage, plastic implants, infectious disease
- Inclusion: Adult, brain hemorrhage, external CSF drain from ventricle
- Exclusion: intraventricular hemorrhage, plastic implants, ECMO, hemodialysis, infectious disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accumulation of plasticizers in transfused patients
Time frame: 3 years
Plasticizer concentrations (mmol/L) will be measured from the plasma of thalassemia major patients two weeks after the last pRBC-transfusion and compared to plasma levels of healthy controls of beta-thalassemia intermedia/minor patient using MANCOVA. Age, sex and liver/kidney retention will be taken into account as covariates and Tukey HSD or Scheffe tests used for even and uneven group sizes, respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Beta-thalassemia and Glioma, run by Medical University of Vienna at 1 site in Austria.
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 10 inclusion and 0 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: opening soon, as of the sponsor's last update on 24 Jul 2024. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Wisgrill, MD, PhD (800-123-4567, lukas.wisgrill@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulation of plasticizers in transfused patients (time frame: 3 years). 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 24 Jul 2024.