Status:
UNKNOWN
Biometric and Biological Data for Diagnosis and Therapy of Pain Patients
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Small Fiber Neuropathy
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Group A: Criteria 1-5 Group B: Criteria 2-5 Group C: Criteria 2-6 Group D: Criteria 2-4
- Small fiber neuropathy (after clinical examination or QST or skin biopsy findings)
- Legal age
- Written declaration of consent
- Persons who are legally competent and mentally capable of following the instructions of the staff
- Sufficient affinity for independent handling of the technology used (PainWatch incl. the corresponding apps) for daily digital pain recording
- 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
- For all Groups:
- Persons who are accommodated in an institution by order of the authorities or courts
- Persons who are in a dependent or employment relationship with the auditor
- 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.
Key Trial Info
Start Date :
October 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04835779
Start Date
October 10 2020
End Date
October 1 2023
Last Update
January 9 2023
Active Locations (1)
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1
Uniklinik RWTH Aachen, Klinik für Palliativmedizin
Aachen, North Rhine-Westphalia, Germany, 52074