NCT05753332

Brief Summary

This cohort study aims to discover the possible effects of PM2.5 exposures on the Nrf2- dependent ferroptosis pathway. This observational cohort's main question is whether PM2.5 exposures will affect the Nrf2- dependent ferroptosis pathway. Participants will be divided into two groups: the control group and the air pollution to detect the biomarkers of the Nrf2- dependent ferroptosis pathway.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 6, 2023

Last Update Submit

February 21, 2023

Conditions

Keywords

PM2.5Nrf2Cognitive functionFerroptosis

Outcome Measures

Primary Outcomes (3)

  • 4HNE level

    Biomarkers of ferroptosis, an indicator of lipid reactive oxygen species

    From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 120 days

  • TNF-α ELISA KIT

    Biomarkers of the proinflammatory cytokines

    From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 120 days

  • mRNA expression of the Nrf2- dependent ferroptosis

    Biomarkers of the Nrf2- dependent ferroptosis

    From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 120 days

Study Arms (2)

The control group

the invited volunteers live in Yangzhou, Jiangsu, China (low PM2.5 level based on previous official PM2.5 records)

The PM2.5 exposure group

the invited volunteers live in Xuzhou, Jiangsu, China (high PM2.5 level based on previous official PM2.5 records)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The control group will be selected from the invited volunteers who live in Yangzhou city via the website, email, and poster. The PM2.5 group will be selected from the invited volunteers who live in Xuzhou city via the website, email, and poster.

You may qualify if:

  • Aged over 18 years old living in this city for more than one year no exposure to any chemistry pollution before

You may not qualify if:

  • Aged below 18 years old neurological disorders; endocrine diseases; cancer significant changes in biomarkers (TNF-α, Nrf2, SLC7A11, GPX4) at the beginning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenjing Zhao

Yangzhou, Jiangsu, 225001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

the enrolled participant's peripheral whole blood samples

Study Officials

  • Ju Gao, Phd

    Affiliated Northern Jiangsu People's Hospital of Yangzhou University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.; attending doctor

Study Record Dates

First Submitted

February 6, 2023

First Posted

March 3, 2023

Study Start

December 1, 2022

Primary Completion

February 25, 2023

Study Completion

March 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations