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Identification of TRP Channels as New Potential Therapeutic Targets in Primary and Secondary Raynaud's Phenomenon. (TRP)

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ClinicalTrials.gov Identifier: NCT03211325
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The investigators seek to perform a comparative transcriptome analysis of TRP channels residing in the skin between primary and scleroderma secondary Raynaud's phenomenon and healthy subjects.

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Isolated Primary Raynaud's Phenomenon (Secondary) Healthy Procedure: Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identification of Transient Receptor Potential (TRP) Channels as New Potential Therapeutic Targets in Primary and Secondary Raynaud's Phenomenon.
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : March 17, 2019
Actual Study Completion Date : June 27, 2019

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Arm Intervention/treatment
Experimental: Healthy

Two sequences of ten healthy volunteers each will be performed :

During the first sequence, a biopsy of the gluteal area and another of the surrounding nail area of a finger will be sampled.Then, the cutaneous blood flux of the hand will be recorded at rest and during cooling and warming periods.

During the second sequence, two other biopsies of the surrounding nail area of two other fingers will be sampled.

Procedure: Biopsy
Experimental: Primary Raynaud's phenomenon

Two sequences of ten primary Raynaud's syndrome each will be performed :

During the first sequence, a biopsy of the gluteal area and another of the surrounding nail area of a finger will be sampled.Then, the cutaneous blood flux of the hand will be recorded at rest and during cooling and warming periods.

During the second sequence, two other biopsies of the surrounding nail area of two other fingers will be sampled.

Procedure: Biopsy
Experimental: Secondary Raynaud's phenomenon

Two sequences of ten patients each will be performed :

During the first sequence, a biopsy of the gluteal area and another of the surrounding nail area of a finger will be sampled.Then, the cutaneous blood flux of the hand will be recorded at rest and during cooling and warming periods.

During the second sequence, two other biopsies of the surrounding nail area of two other fingers will be sampled.

Procedure: Biopsy



Primary Outcome Measures :
  1. Comparison of the expression of mRNA of different TRP channels between the three groups. [ Time Frame: at the moment of the first biopsy ]
    Quantification of the expression of mRNA of TRP channels by RT PCR


Secondary Outcome Measures :
  1. Comparison of the expression of mRNA of different TRP channels between the three groups after a loco regional cooling. [ Time Frame: after cooling (2hours after the first biopsy) ]
    RT PCR

  2. Correlation between the expression of mRNA of different TRP channels and the cutaneous blood flux between the three groups during a loco regional cooling. [ Time Frame: after cooling (2hours after the first biopsy) ]
    RT PCR, laser speckle contrast imaging, infra red thermogrphy, tissue viability imaging

  3. Correlation between the expression of mRNA of different TRP channels and the cutaneous blood flux between the three groups during a loco regional warming at 39°C and 43°C. [ Time Frame: after warming (3 hours after the first biopsy) ]
    RT PCR, laser doppler

  4. Comparison of the expression of mRNA of different TRP channels between the biopsies of an affected area (surrouding nail area) and a non-affected area (gluteal region) in the three groups. [ Time Frame: at the moment of the biopsies ]
    RT PCR

  5. Comparison of expressed micro RNA between the three groups. [ Time Frame: at the moment of the first biopsy ]
    RT PCR

  6. Comparison of the methylation states of CpG clusters found at the level of dysregulated genes. [ Time Frame: at the moment of the first biopsy ]
    RT PCR

  7. Comparison of the proportion of myo fibroblasts with or without pharmacological modulation on the TRP(s) which expression is modified in RP. [ Time Frame: second sequence (The interval between the two sequence must not exceed 180 days) ]
    Immuno fluorescence with an anti-alpha smooth muscle cell antibody



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers :dated and signed written consent
  • Primary Raynaud's patients :
  • dated and signed written consent
  • subject presenting a primary Raynaud's phenomenon non associated to a connectivite. RP crisis are defined by a succession of caracteristic symptoms : a syncopal phase with distal whitening of the fingers, usually followed by a cyanotic phase, and then a hyperhemic phase with the outbreak of painful redness.The syncopal phase is always present, while the two other phases can be less pronounced, or even absent.
  • Sclerodermy secondary Raynaud's patients :
  • dated and signed written consent
  • subject with Raynaud's phenomenon secondary to systemic sclerosis, according to the 2013 EULAR/ACR criteria.

Exclusion Criteria:

  • Minor person or major person protected by the law
  • Exclusion period for any clinical trial including a medication or focusing on a clinical device linked to the pathology
  • Social secutrity scheme non-affiliated person or person who cannot pretend to such a scheme
  • Pregnant woman, parturient or breast-feeding mother
  • Person displaying a digital ulcer or a history of digital ulcer
  • Severe concurrent disease found at oral questioning : evolutive cancer, hepatic insufficiency, history of myocardic infarction in the past five years, angina pectoris
  • Hemodynamic instability
  • Any tobacco consumption
  • Any contraindication to the medication used in this trial :
  • Anesderm ® (lidocain/procain) : Known hypersensitivity, to local amide linking anesthetic or to any other compound of the cream, congenital methemoglobin porphyria
  • Lidocain Aguettant 5 mg/ml without preservative, injectable solution : Known hypersensitivity to lidocain chlorhydrate, to local amide linking anesthetic or to one of its excipients, patients affected with reccurrent porphyrias, administration using intravenous way for children under 5 years
  • Xylocain 10 mg/ml epinephrine 0.005 mg/ml, injectable solution : Known hypersensitivity to lidocain chlorhydrate, to local amide linking anesthetic or to one of its excipients, patients affected with reccurrent porphyrias, administration using intravenous way for children under 5 years, linked to the epinephrined compound : intra vascular way, angina pectoris, ventricular rythm troubles, severe arterial hypertension, obstructive cardiomyopathy, hyper thyroidy, anesthesia with local infiltration on the extermities (fingers, penis).
  • Kalinox ® (MEOPA) : Need for ventilation in pure oxygen, intracranial hypertension, alteration of consciousness, cranial trauma, pneumothorax, emphysema bubble, submarine diving accident, intestinal gas distension, gas bubble from an eye surgery under 3 months, known and non substituted B12 vitamine or folic acid deficiency, neurological disorder of recent onset and non explained.
  • Person deprived from his/her freedom on a judicial or administrative decision, person under a legal protection measure.

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): NCT03211325


Locations
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France
CHU of Grenoble Alpes
Grenoble, Isère, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Sophie Blaise, MD, PhD University Hospital, Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03211325    
Other Study ID Numbers: 38RC15.164
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital, Grenoble:
Transient Receptor Potential Channels
Raynaud's Phenomenon Isolated Primary
Raynaud's Phenomenon (Secondary)
Additional relevant MeSH terms:
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Neoplasm Metastasis
Raynaud Disease
Neoplastic Processes
Neoplasms
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases