Sponsor study identifier
observational
110
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
August 1, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)Autoimmune encephalitis and paraneoplastic neurological syndromes are rare diseases caused by an abnormal immune response toward the nervous system. This can lead to life-threatening symptoms, but is in many cases treatable if a swift and correct diagnosis is made. Antibodies targeting neuronal proteins (i.e. "neuronal antibodies") can be detected in serum or cerebrospinal fluid (CSF) in about half of the patients suffering from these conditions. Although an important part of the diagnostical process of these conditions, diagnosis cannot be made only based on a positive antibody test, but the clinical findings have to be compatible as well. As these conditions are so rare, clinicians might struggle to interpret antibody test results. In this study the investigators aim to estimate the incidence rate of autoimmune encephalitides and paraneoplastic neurological syndromes in the Uppsala-Örebro health care region in Sweden between the years 2015 and 2019. Medical records from patients belonging to the Uppsala-Örebro health care region (a region in the middle of Sweden with a population of approximately 2.1 million), that tested positive for any neuronal antibody in serum or CSF will be studied to obtain clinical, laboratory and radiological data. This data will be used to ascertain if diagnostic criteria are fulfilled as well as to describe clinical characteristics and identifying possible comorbidities.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2019
Actual (reported)January 11, 2021
Actual (reported)January 14, 2021
Actual (reported)August 1, 2022
Actual (reported)August 1, 2022
Actual (reported)Incidence rate of autoimmune encephalitides and paraneoplastic neurological syndromes in the Uppsala-Örebro health care region between 2015-2019
Incidence rate of autoimmune encephalitides and paraneoplastic neurological syndromes in the Uppsala-Örebro health care region based on detection of neuronal antibodies in serum or CSF, with case ascertainment based on review of medical records and application of diagnostic criteria (Graus et al. 2016 and 2021).
5 years
Positivity rate
5 years
False positivity rate
5 years
Estimated incidence rate of autoimmune encephalitides and paraneoplastic neurological syndromes in the Swedish population
5 years
Incidence rates of autoimmune encephalitides and paraneoplastic neurological syndromes
5 years
All patients tested for any neuronal antibody in serum or CSF between 2015 and 2019 in Sweden.
All patients belonging to the Uppsala-Örebro health care region (a region in the middle of Sweden with a population of approximately 2.1 million), that tested positive for any neuronal antibody in serum or cerebrospinal fluid between 2015-2019.
Collection of clinical, laboratory and radiological data from medical records.
Collection of laboratory data.
Extended cohort: All patients in Sweden tested for any neuronal antibody (AMPA 1, AMPA 2, Amphiphysin, CARP VIII, CASPR2, CV2/CRMP5, DPPX, GABA B, GAD65 (\>2000 IU/ml by ELISA in serum, or detected in CSF), glycine receptor, Homer 3, Hu, IgLON5, ITPR1, LGI-1, Ma2/Ta, NMDAR, PCA-2, Tr, Ri, SOX1, VGCC, Yo, Zic4), in serum or CSF between 2015 and 2019. Core cohort: All patients belonging to the Uppsala-Örebro health care region (a region in the middle of Sweden with a population of approximately 2.1 million), that tested positive for any neuronal antibody in serum or cerebrospinal fluid between 2015 and 2019. Patients will be identified by the only five laboratories that perform tests for neuronal antibodies in Sweden.
Uppsala University
Uppsala, Uppland, 75237, Sweden
Joachim Burman, Assoc prof
Uppsala University
Anna Rostedt Punga, Professor
Uppsala University
110 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2021
First Posted
January 14, 2021
Study Start
October 1, 2019
Actual (reported)New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
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Primary Completion
August 1, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)Last Updated
November 9, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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