Assessment of cfDNA-STING Axis as a Potential Pathological Marker in Atopic Dermatitis

April 30, 2026 updated by: Yakun Hu, Zhongda Hospital

An Observational Study on the Correlation Between Circulating Cell-free DNA and Skin Macrophage STING Pathway Activation in Patients With Atopic Dermatitis

Study Overview Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching and skin barrier damage. While researchers know that the immune system is overactive in AD, it is difficult to measure the exact level of "damage" or "inflammation" happening deep within the skin using only a physical exam.

The Purpose of This Study This study investigates a specific "danger signal" called circulating cell-free DNA (cfDNA). When skin cells are damaged or die due to inflammation, they release tiny fragments of DNA into the bloodstream. We believe these fragments might act as a trigger for the immune system, worsening the disease.

What the Study Involves

Researchers will collect blood samples and small skin biopsies from patients with AD and healthy volunteers. The study aims to:

Compare the levels of cfDNA in the blood of AD patients versus healthy individuals.

Determine if higher levels of cfDNA correlate with more severe skin symptoms (measured by scores like SCORAD and EASI).

Examine how immune cells in the skin (macrophages) respond to these DNA fragments through a specific biological switch called the STING pathway.

Potential Impact By understanding this "damage-signal" loop, this research may lead to new ways for doctors to monitor AD severity through simple blood tests and could identify new targets for future anti-inflammatory treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Scientific RationaleAtopic dermatitis (AD) is primarily driven by Type 2 (Th2) immune responses; however, the role of innate immune sensing of damage-associated molecular patterns (DAMPs) in maintaining chronic inflammation is less defined. Cell-free DNA (cfDNA) has emerged as a potent DAMP in various autoimmune conditions. This study explores the hypothesis that cfDNA released during epidermal injury and inflammatory cell turnover in AD serves as a ligand for the cyclic GMP-AMP synthase (cGAS) - Stimulator of Interferon Genes (STING) pathway within the skin microenvironment.Study ObjectivesQuantification of Systemic DAMPs: To quantify plasma cfDNA concentrations in a cohort of AD patients (n=40) compared to age- and sex-matched healthy controls (n=40) using fluorometric assays. Tissue-Level Mechanism: To characterize the local immune landscape via immunofluorescence (IF) staining of skin biopsies. The study focuses on the infiltration density of CD68+ macrophages and the expression/co-localization of STING protein within these cells.MethodologyClinical Assessment: Patients undergo standardized dermatological evaluation to determine disease severity.Bio-sampling: Peripheral blood is collected for baseline hematology and cfDNA isolation. For a subset of patients, 4mm punch biopsies are taken from active lesional skin. Data Analysis: Cross-sectional analysis will be used to determine the diagnostic value of cfDNA and its ability to stratify disease severity (Moderate vs. Severe AD). Immunohistochemical quantification will be used to verify the activation of the STING pathway in situ.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital, Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This group consists of patients diagnosed with Atopic Dermatitis (AD) according to the Hanifin and Rajka criteria or the Williams diagnostic criteria.

Description

Inclusion Criteria:Patients aged older than 18 with a confirmed diagnosis of AD and visible skin lesions.

Exclusion Criteria:Patients who have received systemic immunosuppressants, systemic corticosteroids, or biological agents (e.g., Dupilumab) within the past 4 weeks, or topical treatments within the past 2 weeks, to avoid interference with inflammatory markers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AD
This group consists of patients diagnosed with Atopic Dermatitis (AD) according to the Hanifin and Rajka criteria or the Williams diagnostic criteria.
Biological: blood sampling
One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis.
Control
This group consists of healthy volunteers with no personal or family history of atopic dermatitis, asthma, allergic rhinitis, or other systemic inflammatory and autoimmune diseases.
Biological: blood sampling
One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cfDNA
Time Frame: enrollment
the quantification of circulating cell-free DNA
enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025ZDSYLL537P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy and confidentiality of the study participants in accordance with ethical committee guidelines and data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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