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Spatially Transcriptomics Reveals Molecular Signatures in CRPS

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ClinicalTrials.gov Identifier: NCT05986461
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Collaborator:
Hanyang University
Information provided by (Responsible Party):
Jeeyoun Moon, Seoul National University

Study Description
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Brief Summary:
This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS).

Condition or disease
Complex Regional Pain Syndromes

Detailed Description:

Participants who meet the diagnostic criteria for CRPS, aged 19~80 years, and agree to participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as well as the contralateral side (internal control).

Spatial transcriptomics will be used to identify immune cell signatures and differentially regulated genes (DEGs) in the epidermis, vasculature, sweat gland, and nerve plexus of the involved ipsilateral (vs contralateral) side of the patient's skin.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Days
Official Title: Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome
Actual Study Start Date : July 18, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) [ Time Frame: At the time of biopsy ]
    Intensity of pain (now, weekly avarege, weekly maximum)

  2. Thermography [ Time Frame: At the time of diagnosis ]
    Thermography of the involved limb

  3. Quantitative Sensory Testing (QST) [ Time Frame: At the time of diagnosis ]
    Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)


Biospecimen Retention:   Samples With DNA
Punch biopsied skin

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CRPS
Criteria

Inclusion Criteria:

  • Meets the Budapest diagnostic criteria
  • Consents to participation in this study
  • Aged between 19 and 80 years old
  • Symptoms and/or signs of sensory, vasomotor, and sudomotor changes

Exclusion Criteria:

  • Who do not agree to participate in this study
  • Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986461


Contacts
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Contact: Jee Youn Moon, MD, PhD 82-10-5299-2036 jymoon0901@gmail.com
Contact: Jeongsoo Kim, MD 82-10-4734-6422 dreamsu457@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jee Youn Moon, M.D.    82-10-5299-2036    jymoon0901@gmail.com   
Principal Investigator: Jee Youn Moon, M.D.         
Sponsors and Collaborators
Seoul National University
Hanyang University
Investigators
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Principal Investigator: Jee Youn Moon, MD, PhD Seoul National University Hospital
More Information
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Publications of Results:

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Responsible Party: Jeeyoun Moon, MD, PhD, Seoul National University
ClinicalTrials.gov Identifier: NCT05986461    
Other Study ID Numbers: 2304-052-1421
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Disease
Pathologic Processes
 Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases