Clincosm LogoSign in Get a demo

Spatially Transcriptomics Reveals Molecular Signatures in CRPS

Sponsor
Seoul National University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05986461
Collaborator
Hanyang University (Other)
10
Enrollment
1
Location
17.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome
    Actual Study Start Date :
    Jul 18, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Numerical Rating Scale (NRS) [At the time of biopsy]

      Intensity of pain (now, weekly avarege, weekly maximum)

    2. Thermography [At the time of diagnosis]

      Thermography of the involved limb

    3. Quantitative Sensory Testing (QST) [At the time of diagnosis]

      Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University
    • Hanyang University

    Investigators

    • Principal Investigator: Jee Youn Moon, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeeyoun Moon, MD, PhD, Seoul National University
    ClinicalTrials.gov Identifier:
    NCT05986461
    Other Study ID Numbers:
    • 2304-052-1421
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Complex Regional Pain Syndromes
    Reflex Sympathetic Dystrophy
    Syndrome

    Study Results

    No Results Posted as of Aug 14, 2023