AutoimmunityTATANCT03767712
Trauma as a Trigger for Autoimmunity
An observational study of Autoimmunity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmunity
- What is being tested?
- Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jul 2016to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute pertrochanteric fracture in whom an operation (gamma-nail osteosynthesis) is planned at the University Hospital Basel.
Who may be able to join
- pertrochanteric femoral fracture (≤7 days)
- planned gamma nail osteosynthesis
- ability to give written informed consent
Who cannot join
- Severe hepatic and renal failure
- current active oncological disease
- current immunosuppressive or biological therapy
- known systemic autoimmune disease
- foreseeable lack of complete follow-up (e.g. due to generally poor health)
- cognitive impairment (delirium, dementia, alteration of consciousness)
- insufficient knowledge of project language
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study
To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.
Read the detailed description
This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.
- Conditions
- Autoimmunity
- Being tested
- Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.
- Keywords
- trauma, immunological reaction to trauma, pertrochanteric femoral fracture, antinuclear antibodies, activation of innate immunity, adaptive immunity
- Medical subject headings
- Autoimmune Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.Diagnostic test
To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ANA
Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics
Measured: Preoperative (1-2 days preoperative) and 12 weeks postoperative
Secondary outcomes (7)
Change in ANA
Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)
Measured: 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)
serum level of Anti-dsDNA (U/ml)
Measured: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against Anti-Cardiolipin
serum level of Anti-Cardiolipin (U/ml)
Measured: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against complement component C1q (Anti-C1q)
serum level of C1q (U/ml)
Measured: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)
serum level of Anti-SSA/Ro (U/ml)
Measured: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells
Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells (cells/ml)
Measured: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)
Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)
Measured: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start4 Jul 2016
- Primary completion23 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutoimmunityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliska Potlukova, PhD, Principal investigator, Klinik für Innere Medizin, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767712
- Sponsor's protocol ID
- 2016-00895, me16Potlukova
- Other IDs
- 2016
- Acronym
- TATA
- Status last verified
- Apr 2020
- First submitted
- 4 Dec 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03767712
- Acronym / sponsor ID
- TATA / 2016-00895, me16Potlukova
- Conditions
- Autoimmunity
- Keywords
- trauma, immunological reaction to trauma, pertrochanteric femoral fracture, antinuclear antibodies, activation of innate immunity, adaptive immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.
Detailed description
This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute pertrochanteric fracture in whom an operation (gamma-nail osteosynthesis) is planned at the University Hospital Basel.
Key inclusion criteria (3 listed)
- pertrochanteric femoral fracture (≤7 days)
- planned gamma nail osteosynthesis
- ability to give written informed consent
Key exclusion criteria (8 listed)
- Severe hepatic and renal failure
- current active oncological disease
- current immunosuppressive or biological therapy
- known systemic autoimmune disease
- foreseeable lack of complete follow-up (e.g. due to generally poor health)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used) | Diagnostic test | – |
Primary outcome
Change in ANA
Time frame: Preoperative (1-2 days preoperative) and 12 weeks postoperative
Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics
7 secondary outcomes
Change in ANA
Time frame: 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)
Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against Anti-Cardiolipin
Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against complement component C1q (Anti-C1q)
Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)
Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells
Time frame: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)
Time frame: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliska Potlukova, PhD principal investigator
Klinik für Innere Medizin, Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmunity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ANA (time frame: Preoperative (1-2 days preoperative) and 12 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.