UnknownNot Applicable

Biometric and Biological Data for Diagnosis and Therapy of Pain Patients

Germany68 participantsStarted 2020-10-10

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PainWatch Data

Timeframe: 12 months

PainWatch Data

Timeframe: 12 months

PainWatch Data

Timeframe: 12 months

Weather Data tracked according to GPS Location

Timeframe: 12 months

Weather Data tracked according to GPS Location

Timeframe: 12 months

Weather Data tracked according to GPS Location

Timeframe: 12 months

Test result QST

Timeframe: 12 months

Test result PREP (over the same back of the foot as in QST measurement)

Timeframe: 12 months

Trial details

NCT IDNCT04835779

SponsorRWTH Aachen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10

Contact for this trial

Roman Rolke, Prof. Dr.

+49 241 8080880 rrolke@ukaachen.de

View on ClinicalTrials.gov More Small Fiber Neuropathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

What they're measuring

PainWatch Data

Timeframe: 12 months

PainWatch Data

Timeframe: 12 months

PainWatch Data

Timeframe: 12 months

Weather Data tracked according to GPS Location

Timeframe: 12 months

Weather Data tracked according to GPS Location

Timeframe: 12 months

Weather Data tracked according to GPS Location

Timeframe: 12 months

Test result QST

Timeframe: 12 months

Test result PREP (over the same back of the foot as in QST measurement)

Timeframe: 12 months