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

NCT07573735 | Recruiting DMC

• 1 other identifier: 2025ZDSYLL537P01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis (Eczema)

Outcome Measures

Primary Outcomes (1)

• cfDNA

  the quantification of circulating cell-free DNA

  enrollment

Study Arms (2)

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

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

Interventions

blood sampling BIOLOGICAL

One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis.

AD; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (4)

• Dong L, Hou YR, Xu N, Gao XQ, Sun Z, Yang QK, Wang LN. Cyclic GMP-AMP synthase recognizes the physical features of DNA. Acta Pharmacol Sin. 2025 Feb;46(2):264-270. doi: 10.1038/s41401-024-01369-7. Epub 2024 Aug 7.

  PMID: 39112770 BACKGROUND

• Decout A, Katz JD, Venkatraman S, Ablasser A. The cGAS-STING pathway as a therapeutic target in inflammatory diseases. Nat Rev Immunol. 2021 Sep;21(9):548-569. doi: 10.1038/s41577-021-00524-z. Epub 2021 Apr 8.

  PMID: 33833439 BACKGROUND

• Kopfnagel V, Dreyer S, Zeitvogel J, Pieper DH, Buch A, Sodeik B, Rademacher F, Harder J, Werfel T. Free human DNA attenuates the activity of antimicrobial peptides in atopic dermatitis. Allergy. 2021 Oct;76(10):3145-3154. doi: 10.1111/all.14992. Epub 2021 Jul 16.

  PMID: 34176149 BACKGROUND

• Schuler CF 4th, Tsoi LC, Billi AC, Harms PW, Weidinger S, Gudjonsson JE. Genetic and Immunological Pathogenesis of Atopic Dermatitis. J Invest Dermatol. 2024 May;144(5):954-968. doi: 10.1016/j.jid.2023.10.019. Epub 2023 Dec 11.

  PMID: 38085213 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood is collected for hematology and cfDNA isolation. For a subset of patients, 4mm punch biopsies are taken from active lesional skin

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)