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Biometric and Biological Data for Diagnosis and Therapy of Pain Patients (Bio2Treat)

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ClinicalTrials.gov Identifier: NCT04835779
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Prof. Dr. Roman Rolke, RWTH Aachen University

Brief Summary:
In order to meet the challenge of an unambiguous diagnosis and effective therapy of SFN or the prognosis of susceptibility to the development of SFN, this project aims to create a data basis on which software will be developed during the project. This software should later be able to combine (integrate) quantifiable biometric data collected from the patient (both objectively measured and patient reported parameters) with the results of biological analyses of the patient's own nerve cells from stem cells. We expect that the patient-specific combination and correlation of biometric and biological data can lead to a significant improvement in the diagnosis, prognosis and therapy of chronic pain. The initial data collection required for the development of such a software (Bio2Integrate) will be carried out in three different project parts: Bio2Watch, Bio2Patient and Bio2Cell

Condition or disease
Small Fiber Neuropathy

Detailed Description:

Bio2Watch: In this clinical project part biometric patient data of 24 SFN patients, 3 cancer patients and 21 subjects (control group) will be collected for a period of one year using a PainWatch. The term PainWatch includes an Apple Watch 5 with iPhone 8 and installed app for pain recording. With the aid of the PainWatch, the personal pain sensation in everyday life is documented and personal data such as the pulse rate and the daily number of steps, as well as environmental data, such as the prevailing air pressure, humidity and temperature are recorded. The aim is to use these data as a basis for initial indications of pain-inducing stimuli or combinations of stimuli.

Bio2Patient: In this clinical project part clinically quantifiable tests are carried out, such as quantitative sensory testing (QST), which examines subjective thermal and mechanical sensory perception and pain thresholds. The goal is to determine a specific pain phenotype. In addition, pain evoked potentials (PREPs) are performed to draw conclusions about the function of thin nerve fibers (pain fibers), including projection to the brain. Supplementary SF-36 pain questionnaires are completed to assess the quality of life.

Bio2Cell: In the cell-based project part induced pluripotent stem cells (iPS cells) are produced from blood cells of SFN patients, cancer patients and volunteers. These cells will be differentiated into sensory neurons that are relevant in pain processing, so-called nociceptors. Since these nociceptors are derived from the individual patient, they carry the individual genetic characteristics of the patient. These neurons are then analyzed by multi-electrode arrays (MEA). With this method environmental influences such as temperature and air pressure or drugs on the pathophysiology of the patient's are investigated. The main goal is to simulate the conditions, which lead to pain sensation in the context of Bio2Watch and Bio2Patient.

Bio2Integrate: The results from Bio2Watch, Bio2Patient and Bio2Cell will then flow into the software to be developed during the project. Thus, in addition to the identification of stimuli that stimulate pain as well as a genetic correlation to certain markers will be possible. In addition, the targeted modification of the cellular properties of the patient's own sensory neurons through the application of the chemotherapeutic agent can be investigated. To this end, measurements will be made on the cells before and after the application of the substance and compare them with each other. This is the basis for components of the "machine learning " of the Bio2Integrate software.The results of the clinical subprojects are thus an essential component of Bio2Integrate.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biometric and Biological Data for Diagnosis and Therapy of Pain Patients German: Biometrische Und Biologische Daten für Die Diagnose Und Therapie Bei Schmerzpatienten
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort
SFN Patients
Patients with diagnosed Small Fibre Neuropathy
Patients undergoing chemotherapy
Patients undergoing chemotherapy and are expected to develop SFN as a result
Healthy Volunteer
Healthy test person



Primary Outcome Measures :
  1. PainWatch Data [ Time Frame: 12 months ]
    pulse rate (/min)

  2. PainWatch Data [ Time Frame: 12 months ]
    number of steps

  3. PainWatch Data [ Time Frame: 12 months ]
    pain perception via App (Questionnaire, pain scale 1-10)

  4. Weather Data tracked according to GPS Location [ Time Frame: 12 months ]
    Temperature (°C)

  5. Weather Data tracked according to GPS Location [ Time Frame: 12 months ]
    Air pressure (Pa)

  6. Weather Data tracked according to GPS Location [ Time Frame: 12 months ]
    Humidity (%)

  7. Test result QST [ Time Frame: 12 months ]
    Measurement exclusively above the back of the foot that is clinically more severely affected by the SFN, in a balanced row alternately above the right or left foot; one back of the foot as test site per subject

  8. Test result PREP (over the same back of the foot as in QST measurement) [ Time Frame: 12 months ]
    P1 Latency (ms)

  9. Test result PREP (over the same back of the foot as in QST measurement) [ Time Frame: 12 months ]
    Peak-to-Peak (microV)

  10. Test result PREP (over the same back of the foot as in QST measurement) [ Time Frame: 12 months ]
    Current intensity (mA)

  11. Result SF 36 Questionnaire [ Time Frame: 12months ]
    Result SF 36 Questionnaire (different scales per question)

  12. Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]
    Spontaneous activity

  13. Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]
    Synchronicity

  14. Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]
    Field potential properties

  15. Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]
    Activity inducing stimuli

  16. Efficiency of reprogramming and differentiation of iPS cells [ Time Frame: 12 months ]
    Success of differentiation will be measured by flow cytometry at around d10 of differentiation. The percentage of p75 (CD271)-expressing cells will be meassured. The differentiation is defined as successful if more than 30% of cells express p75. Only those differentiations will be used for MEA-Recordings.


Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
SFN Patients (Group A): Patients diagnosed with Small Fibre Neuropathia Healthy Volunteers (Group B): Healthy grown-up Volunteers Patients undergoing chemotherapy (Group C): Patients with imminent initiation of neurotoxic chemotherapy in cancer with solid tumors (preferably of the gastrointestinal tract) with the side-effect of SFN development. There are no plans for follow-up recruitment in case no neuropathy develops after chemo.
Criteria

Inclusion Criteria:

Group A: Criteria 1-5 Group B: Criteria 2-5 Group C: Criteria 2-6

  1. Small fiber neuropathy (after clinical examination or QST or skin biopsy findings)
  2. Legal age
  3. Written declaration of consent
  4. Persons who are legally competent and mentally capable of following the instructions of the staff
  5. Sufficient affinity for independent handling of the technology used (PainWatch incl. the corresponding apps) for daily digital pain recording
  6. Imminent initiation of neurotoxic chemotherapy in cancer with solid tumors (preferably of the gastrointestinal tract) There are no plans for follow-up recruitment in case no neuropathy develops after chemo.

Exclusion Criteria:

For all Groups:

  1. Persons who are accommodated in an institution by order of the authorities or courts
  2. Persons who are in a dependent or employment relationship with the auditor
  3. For test persons: Exclusion, if they carry a known pain-relevant genetic variant/mutation or suffer from a chronic pain disorder analogous to migraine or chronic back pain.

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): NCT04835779


Contacts
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Contact: Roman Rolke, Prof. Dr. +49 241 8080880 rrolke@ukaachen.de
Contact: Lampert Angelika, Prof. Dr. +49 241 80 88811 alampert@ukaachen.de

Locations
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Germany
Uniklinik RWTH Aachen, Klinik für Palliativmedizin Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Contact: Roman Rolke, Prof.Dr.med    +49-241-8080880    rrolke@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Grünenthal GmbH
Investigators
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Principal Investigator: Roman Rolke, Prof. Dr. Universitätsklinikum Aachen, AöR
Publications:

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Responsible Party: Prof. Dr. Roman Rolke, Direktor Klinik für Palliativmedizin, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04835779    
Other Study ID Numbers: 18-018
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
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
Keywords provided by Prof. Dr. Roman Rolke, RWTH Aachen University:
Pain
SFN
Additional relevant MeSH terms:
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Small Fiber Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases