Cerebrovascular DisordersCLEANNCT07140601
Environmental Pollutants and Neurological Disorders
An observational study of Cerebrovascular Disorders and Brain Tumours, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Environmental pollutants have emerged as a major global health concern, with growing evidence linking exposure to both traditional contaminants such as heavy metals (lead, mercury, cadmium, arsenic) and novel pollutants-including micro- and nanoplastics, per- and polyfluoroalkyl substances (PFAS), antibiotics, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disorders, Brain Tumours, Alzheimer Dementia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2027
- How long will I take part?
- 24 Months
- 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: Patients with brain tumours or cerebrovascular diseases who need surgical resection.
Who may be able to join
- 18 years of age or older;
- Able to give informed consent to participate in the research.
Who cannot join
- Refusal to participate.
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Runting Li, MD, +86 15753166690, tt18080lrt@163.com
About this study
Official title: Environmental Pollutants and Neurological Disorders: Clinical and Mechanistic Study
Environmental pollutants have emerged as a major global health concern, with growing evidence linking exposure to both traditional contaminants such as heavy metals (lead, mercury, cadmium, arsenic) and novel pollutants-including micro- and nanoplastics, per- and polyfluoroalkyl substances (PFAS), antibiotics, and endocrine-disrupting chemicals-to adverse neurological outcomes. These pollutants can cross or disrupt the blood-brain barrier, accumulate in neural tissue, and trigger oxidative stress, inflammation, epigenetic modifications, and metabolic reprogramming.
Brain tumours and cerebrovascular diseases represent two major categories of neurosurgical disorders with high morbidity and mortality. However, their interaction with environmental pollutant exposure remains poorly understood. Recent studies suggest that pollutant-induced molecular alterations, such as aberrant DNA methylation, lipid metabolism disruption, and neurovascular endothelial dysfunction, may contribute to tumour initiation, malignant progression, aneurysm formation, and stroke occurrence.
Given the increasing human exposure to these pollutants and the lack of large-scale clinical data, it is urgent to establish a systematic investigation in neurosurgical patients. This study aims to profile pollutant exposure (heavy metals, PFAS, microplastics, and other novel contaminants) using multi-biospecimen analysis (blood, urine, hair, tumour and peri-tumour tissues), and to explore their mechanistic links to the pathogenesis of brain tumours and cerebrovascular diseases. The findings are expected to provide new evidence for understanding environment-brain interactions and to identify potential biomarkers for disease risk stratification and prevention.
- Conditions
- Cerebrovascular Disorders, Brain Tumours, Alzheimer Dementia
- Keywords
- Environmental Pollutants, Exposomics, Pathogenic Mechanisms, Neurological Disorders, Neurosurgical Patients
- Medical subject headings
- Cerebrovascular Disorders, Brain Neoplasms, Alzheimer Disease, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from the sample collection date to death due to any cause. All other participants will be censored at the last date known to be alive.
Measured: Until death or study completion (24 months)
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the duration of time from sample collection date to time of progression or death, whichever occurs first.
Measured: Until progression or death or study completion (24 months)
modified Rankin Scale (mRS)
Patients' mRS scores at 90 days after sample collection.
Measured: 90 days after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Research Academy of Environmental Sciences, Nanjing University, Nanjing Institute of Environmental Sciences, Chinese Academy of Environmental Planning, Peking Union Medical College, National Human Brain Bank for Development and Function
- Responsible party
- Principal investigator, Xiaolin Chen, MD, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140601
- Sponsor's protocol ID
- KY2024-252-02
- Other IDs
- 2024ZD0539700
- Acronym
- CLEAN
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Pollutants and Neurological Disorders: Clinical and Mechanistic Study
- ClinicalTrials.gov ID
- NCT07140601
- Acronym / sponsor ID
- CLEAN / KY2024-252-02
- Conditions
- Cerebrovascular Disorders, Brain Tumours, Alzheimer Dementia
- Keywords
- Environmental Pollutants, Exposomics, Pathogenic Mechanisms, Neurological Disorders, Neurosurgical Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Chinese Research Academy of Environmental Sciences, Nanjing University, Nanjing Institute of Environmental Sciences, Chinese Academy of Environmental Planning, Peking Union Medical College, National Human Brain Bank for Development and Function
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Aug 2025 (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.
Environmental pollutants have emerged as a major global health concern, with growing evidence linking exposure to both traditional contaminants such as heavy metals (lead, mercury, cadmium, arsenic) and novel pollutants-including micro- and nanoplastics, per- and polyfluoroalkyl substances (PFAS), antibiotics, and endocrine-disrupting chemicals-to adverse neurological outcomes. These pollutants can cross or disrupt the blood-brain barrier, accumulate in neural tissue, and trigger oxidative stress, inflammation, epigenetic modifications, and metabolic reprogramming.
Brain tumours and cerebrovascular diseases represent two major categories of neurosurgical disorders with high morbidity and mortality. However, their interaction with environmental pollutant exposure remains poorly understood. Recent studies suggest that pollutant-induced molecular alterations, such as aberrant DNA methylation, lipid metabolism disruption, and neurovascular endothelial dysfunction, may contribute to tumour initiation, malignant progression, aneurysm formation, and stroke occurrence.
Given the increasing human exposure to these pollutants and the lack of large-scale clinical data, it is urgent to establish a systematic investigation in neurosurgical patients. This study aims to profile pollutant exposure (heavy metals, PFAS, microplastics, and other novel contaminants) using multi-biospecimen analysis (blood, urine, hair, tumour and peri-tumour tissues), and to explore their mechanistic links to the pathogenesis of brain tumours and cerebrovascular diseases. The findings are expected to provide new evidence for understanding environment-brain interactions and to identify potential biomarkers for disease risk stratification and prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain tumours or cerebrovascular diseases who need surgical resection.
Key inclusion criteria (2 listed)
- 18 years of age or older;
- Able to give informed consent to participate in the research.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Pregnant or breastfeeding woman.
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
Overall Survival (OS)
Time frame: Until death or study completion (24 months)
OS is defined as the time from the sample collection date to death due to any cause. All other participants will be censored at the last date known to be alive.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Until progression or death or study completion (24 months)
modified Rankin Scale (mRS)
Time frame: 90 days after sample collection
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 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebrovascular Disorders
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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 Cerebrovascular Disorders and Brain Tumours, run by Beijing Tiantan Hospital at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 China. 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 Runting Li, MD (+86 15753166690, tt18080lrt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Until death or study completion (24 months)). 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 Aug 2025.