xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986461</url>
    </required_header>
    <id_info>
      <org_study_id>2304-052-1421</org_study_id>
      <nct_id>NCT05986461</nct_id>
    </id_info>
    <brief_title>Spatially Transcriptomics Reveals Molecular Signatures in CRPS</brief_title>
    <official_title>Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hanyang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul National University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This observational study aims to understand phenotype-specific molecular signatures in&#xD;
        patients with complex regional pain syndrome (CRPS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants who meet the diagnostic criteria for CRPS, aged 19~80 years, and agree to&#xD;
        participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as&#xD;
        well as the contralateral side (internal control).&#xD;
  &#xD;
        Spatial transcriptomics will be used to identify immune cell signatures and differentially&#xD;
        regulated genes (DEGs) in the epidermis, vasculature, sweat gland, and nerve plexus of the&#xD;
        involved ipsilateral (vs contralateral) side of the patient's skin.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>3 Days</target_duration>
    <primary_outcome>
      <measure>Numerical Rating Scale (NRS)</measure>
      <time_frame>At the time of biopsy</time_frame>
      <description>Intensity of pain (now, weekly avarege, weekly maximum)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Thermography</measure>
      <time_frame>At the time of diagnosis</time_frame>
      <description>Thermography of the involved limb</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitative Sensory Testing (QST)</measure>
      <time_frame>At the time of diagnosis</time_frame>
      <description>Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)</description>
    </primary_outcome>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Complex Regional Pain Syndromes</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Punch biopsied skin&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with CRPS&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meets the Budapest diagnostic criteria&#xD;
  &#xD;
            -  Consents to participation in this study&#xD;
  &#xD;
            -  Aged between 19 and 80 years old&#xD;
  &#xD;
            -  Symptoms and/or signs of sensory, vasomotor, and sudomotor changes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Who do not agree to participate in this study&#xD;
  &#xD;
            -  Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking&#xD;
               anticoagulant drugs)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jee Youn Moon, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jee Youn Moon, MD, PhD</last_name>
      <phone>82-10-5299-2036</phone>
      <email>jymoon0901@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeongsoo Kim, MD</last_name>
      <phone>82-10-4734-6422</phone>
      <email>dreamsu457@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jee Youn Moon, M.D.</last_name>
        <phone>82-10-5299-2036</phone>
        <email>jymoon0901@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Jee Youn Moon, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <results_reference>
      <citation>Taylor SS, Noor N, Urits I, Paladini A, Sadhu MS, Gibb C, Carlson T, Myrcik D, Varrassi G, Viswanath O. Complex Regional Pain Syndrome: A Comprehensive Review. Pain Ther. 2021 Dec;10(2):875-892. doi: 10.1007/s40122-021-00279-4. Epub 2021 Jun 24. Erratum In: Pain Ther. 2021 Jul 26;:</citation>
      <PMID>34165690</PMID>
    </results_reference>
    <results_reference>
      <citation>Rao A, Barkley D, Franca GS, Yanai I. Exploring tissue architecture using spatial transcriptomics. Nature. 2021 Aug;596(7871):211-220. doi: 10.1038/s41586-021-03634-9. Epub 2021 Aug 11.</citation>
      <PMID>34381231</PMID>
    </results_reference>
    <results_reference>
      <citation>Birklein F, Drummond PD, Li W, Schlereth T, Albrecht N, Finch PM, Dawson LF, Clark JD, Kingery WS. Activation of cutaneous immune responses in complex regional pain syndrome. J Pain. 2014 May;15(5):485-95. doi: 10.1016/j.jpain.2014.01.490. Epub 2014 Jan 23.</citation>
      <PMID>24462502</PMID>
    </results_reference>
    <results_reference>
      <citation>Escolano-Lozano F, Gries E, Schlereth T, Dimova V, Baka P, Vlckova E, Konig S, Birklein F. Local and Systemic Expression Pattern of MMP-2 and MMP-9 in Complex Regional Pain Syndrome. J Pain. 2021 Oct;22(10):1294-1302. doi: 10.1016/j.jpain.2021.04.002. Epub 2021 Apr 20.</citation>
      <PMID>33892152</PMID>
    </results_reference>
    <results_reference>
      <citation>Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403.</citation>
      <PMID>27365449</PMID>
    </results_reference>
    <results_reference>
      <citation>Ji AL, Rubin AJ, Thrane K, Jiang S, Reynolds DL, Meyers RM, Guo MG, George BM, Mollbrink A, Bergenstrahle J, Larsson L, Bai Y, Zhu B, Bhaduri A, Meyers JM, Rovira-Clave X, Hollmig ST, Aasi SZ, Nolan GP, Lundeberg J, Khavari PA. Multimodal Analysis of Composition and Spatial Architecture in Human Squamous Cell Carcinoma. Cell. 2020 Jul 23;182(2):497-514.e22. doi: 10.1016/j.cell.2020.05.039. Epub 2020 Jun 23. Erratum In: Cell. 2020 Sep 17;182(6):1661-1662.</citation>
      <PMID>32579974</PMID>
    </results_reference>
    <results_reference>
      <citation>Andronic D, Andronic O, Juengel A, Berli MC, Distler O, Brunner F. Skin biomarkers associated with complex regional pain syndrome (CRPS) Type I: a systematic review. Rheumatol Int. 2022 Jun;42(6):937-947. doi: 10.1007/s00296-021-05061-5. Epub 2022 Jan 8.</citation>
      <PMID>34997300</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University</investigator_affiliation>
      <investigator_full_name>Jeeyoun Moon</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Complex Regional Pain Syndromes</mesh_term>
      <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986461
  org study id: 2304-052-1421
  nct id: NCT05986461
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This observational study aims to understand phenotype-specific molecular signatures in
        patients with complex regional pain syndrome (CRPS).
  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.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Numerical Rating Scale (NRS)
  time frame: At the time of biopsy
  description: Intensity of pain (now, weekly avarege, weekly maximum)
  measure: Thermography
  time frame: At the time of diagnosis
  description: Thermography of the involved limb
  measure: Quantitative Sensory Testing (QST)
  time frame: At the time of diagnosis
  description: Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)
  Punch biopsied skin
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jee Youn Moon, MD, PhD
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Jee Youn Moon, MD, PhD
  phone: 82-10-5299-2036
  email: jymoon0901@gmail.com
  last name: Jeongsoo Kim, MD
  phone: 82-10-4734-6422
  email: dreamsu457@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Korea, Republic of
  citation: Taylor SS, Noor N, Urits I, Paladini A, Sadhu MS, Gibb C, Carlson T, Myrcik D, Varrassi G, Viswanath O. Complex Regional Pain Syndrome: A Comprehensive Review. Pain Ther. 2021 Dec;10(2):875-892. doi: 10.1007/s40122-021-00279-4. Epub 2021 Jun 24. Erratum In: Pain Ther. 2021 Jul 26;:
  PMID: 34165690
  citation: Rao A, Barkley D, Franca GS, Yanai I. Exploring tissue architecture using spatial transcriptomics. Nature. 2021 Aug;596(7871):211-220. doi: 10.1038/s41586-021-03634-9. Epub 2021 Aug 11.
  PMID: 34381231
  citation: Birklein F, Drummond PD, Li W, Schlereth T, Albrecht N, Finch PM, Dawson LF, Clark JD, Kingery WS. Activation of cutaneous immune responses in complex regional pain syndrome. J Pain. 2014 May;15(5):485-95. doi: 10.1016/j.jpain.2014.01.490. Epub 2014 Jan 23.
  PMID: 24462502
  citation: Escolano-Lozano F, Gries E, Schlereth T, Dimova V, Baka P, Vlckova E, Konig S, Birklein F. Local and Systemic Expression Pattern of MMP-2 and MMP-9 in Complex Regional Pain Syndrome. J Pain. 2021 Oct;22(10):1294-1302. doi: 10.1016/j.jpain.2021.04.002. Epub 2021 Apr 20.
  PMID: 33892152
  citation: Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403.
  PMID: 27365449
  citation: Ji AL, Rubin AJ, Thrane K, Jiang S, Reynolds DL, Meyers RM, Guo MG, George BM, Mollbrink A, Bergenstrahle J, Larsson L, Bai Y, Zhu B, Bhaduri A, Meyers JM, Rovira-Clave X, Hollmig ST, Aasi SZ, Nolan GP, Lundeberg J, Khavari PA. Multimodal Analysis of Composition and Spatial Architecture in Human Squamous Cell Carcinoma. Cell. 2020 Jul 23;182(2):497-514.e22. doi: 10.1016/j.cell.2020.05.039. Epub 2020 Jun 23. Erratum In: Cell. 2020 Sep 17;182(6):1661-1662.
  PMID: 32579974
  citation: Andronic D, Andronic O, Juengel A, Berli MC, Distler O, Brunner F. Skin biomarkers associated with complex regional pain syndrome (CRPS) Type I: a systematic review. Rheumatol Int. 2022 Jun;42(6):937-947. doi: 10.1007/s00296-021-05061-5. Epub 2022 Jan 8.
  PMID: 34997300
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University
  investigator full name: Jeeyoun Moon
  investigator title: MD, PhD
  mesh term: Complex Regional Pain Syndromes
  mesh term: Reflex Sympathetic Dystrophy
  mesh term: Syndrome
  sharing ipd: No