Spatially Transcriptomics Reveals Molecular Signatures in CRPS

May 27, 2024 updated by: Jeeyoun Moon, Seoul National University

Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jee Youn Moon, M.D.
        • 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

No

Sampling Method

Non-Probability Sample

Study Population

Patients with CRPS

Description

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)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS)
Time Frame: At the time of biopsy
Intensity of pain (now, weekly avarege, weekly maximum)
At the time of biopsy
Thermography
Time Frame: At the time of diagnosis
Thermography of the involved limb
At the time of diagnosis
Quantitative Sensory Testing (QST)
Time Frame: At the time of diagnosis
Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)
At the time of diagnosis

Collaborators and Investigators

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

Sponsor

Seoul National University

Collaborators

Hanyang University

Investigators

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

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)

July 18, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2304-052-1421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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