Clinical Trial

International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

Dimensions: NCT01582763

Investigators

Jakobsen (15)
James Holt (72)
Min Htut (76)

Affiliations

Organisations

  1. (1) Erasmus MC, grid.5645.2
  2. (2) Buenos Aires British Hospital, grid.414382.8
  3. (3) Hospital César Milstein, grid.414727.3
  4. (4) Hospital de Clínicas "José de San Martín", grid.412714.5
  5. (5) Garrahan Hospital, grid.414531.6
  6. (6) Royal Melbourne Hospital, grid.416153.4
  7. (7) Concord Repatriation General Hospital, grid.414685.a
  8. (8) Dhaka Medical College and Hospital, grid.413674.3
  9. (9) International Centre for Diarrhoeal Disease Research, grid.414142.6
  10. (10) Cliniques Universitaires Saint-Luc, grid.48769.34
  11. (11) Universitair Ziekenhuis Leuven, grid.410569.f
  12. (12) Affiliated Hospital of Jining Medical University, grid.452252.6
  13. (13) Aalborg Hospital, grid.27530.33, North Denmark Region
  14. (14) Aarhus University Hospital, grid.154185.c, Central Denmark Region
  15. (15) Copenhagen University Hospital, grid.4973.9, Capital Region
  16. (16) Glostrup Hospital, grid.411719.b
  17. (17) Odense University Hospital, grid.7143.1, Southern Denmark Region
  18. (18) Hôpital de la Timone, grid.411266.6
  19. (19) Centre Hospitalier Universitaire de Nantes, grid.277151.7
  20. (20) University Hospital Aachen, grid.412301.5
  21. (21) University of Cologne, grid.6190.e
  22. (22) University Hospital Carl Gustav Carus, grid.412282.f
  23. (23) Heinrich Heine University Düsseldorf, grid.411327.2
  24. (24) Universitätsklinikum des Saarlandes, grid.411937.9
  25. (25) University Hospital Würzburg, grid.411760.5
  26. (26) University Of Thessaly, grid.410558.d
  27. (27) University of Genoa, grid.5606.5
  28. (28) University of Messina, grid.10438.3e
  29. (29) Luigi Sacco Hospital, grid.144767.7
  30. (30) San Raffaele Hospital, grid.18887.3e
  31. (31) University of Milan, grid.4708.b
  32. (32) University of Modena and Reggio Emilia, grid.7548.e
  33. (33) University of Milano-Bicocca, grid.7563.7
  34. (34) University of Naples Federico II, grid.4691.a
  35. (35) University of Padua, grid.5608.b
  36. (36) Policlinico Tor Vergata, grid.413009.f
  37. (37) Azienda Ospedaliera Sant'Andrea, grid.415230.1
  38. (38) Chiba University, grid.136304.3
  39. (39) Kindai University, grid.258622.9
  40. (40) Dokkyo Medical University, grid.255137.7
  41. (41) National Defense Medical College, grid.416614.0
  42. (42) Toho University, grid.265050.4
  43. (43) University of Malaya, grid.10347.31
  44. (44) Academic Medical Center, grid.5650.6
  45. (45) Rode Kruis Ziekenhuis, grid.415746.5
  46. (46) Reinier de Graaf Hospital, grid.415868.6
  47. (47) Jeroen Bosch Ziekenhuis, grid.413508.b
  48. (48) Medisch Centrum Haaglanden, grid.414842.f
  49. (49) Albert Schweitzer Ziekenhuis, grid.413972.a
  50. (50) Elkerliek Ziekenhuis, grid.414480.d
  51. (51) Westfriesgasthuis, grid.476832.c
  52. (52) Leiden University Medical Center, grid.10419.3d
  53. (53) Maastricht University Medical Centre, grid.412966.e
  54. (54) Canisius-Wilhelmina Ziekenhuis, grid.413327.0
  55. (55) Maasstad Ziekenhuis, grid.416213.3
  56. (56) Sint Franciscus Gasthuis, grid.461048.f
  57. (57) Elisabeth-TweeSteden Ziekenhuis, grid.416373.4
  58. (58) University of Cape Town, grid.7836.a
  59. (59) Bellvitge University Hospital, grid.411129.e
  60. (60) Hospital de Sant Pau, grid.413396.a
  61. (61) Hospital Universitario Reina Sofía, grid.411349.a
  62. (62) Hospital Universitario Infanta Sofía, grid.414758.b
  63. (63) Central University Hospital of Asturias, grid.411052.3
  64. (64) Complejo Hospitalario de Navarra, grid.497559.3
  65. (65) Marqués de Valdecilla University Hospital, grid.411325.0
  66. (66) Queen Elizabeth Hospital Birmingham, grid.415490.d
  67. (67) Bradford Royal Infirmary, grid.418447.a
  68. (68) Addenbrooke's Hospital, grid.120073.7
  69. (69) Western General Hospital, grid.417068.c
  70. (70) University of Glasgow, grid.8756.c
  71. (71) Leeds General Infirmary, grid.418161.b
  72. (72) Walton Centre, grid.416928.0
  73. (73) Charing Cross Hospital, grid.413820.c
  74. (74) King's College Hospital, grid.46699.34
  75. (75) National Hospital for Neurology and Neurosurgery, grid.436283.8
  76. (76) St George's Hospital, grid.464688.0
  77. (77) James Cook University Hospital, grid.411812.f
  78. (78) Royal Victoria Infirmary, grid.419334.8
  79. (79) University of Oxford, grid.4991.5
  80. (80) Royal Hallamshire Hospital, grid.416126.6
  81. (81) Pinderfields Hospital, grid.415005.5

Sponsors/collaborators

Abstract

International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS). The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease. Detailed Description GBS is a post-infectious immune-mediated polyradiculoneuropathy with a highly diverse clinical course and outcome despite partially effective forms of treatment(immunoglobulins and plasma exchange). Outcome in patients with GBS has not improved in the last two decades. At present about 10 to 20% of patients remain severely disabled and about 5% die. One explanation for this stagnation is the highly variable clinical course of GBS and the lack of knowledge about the factors that determine the clinical course in individual patients with GBS. GBS may consist of distinct pathogenic subgroups, in which disease onset and progression is influenced by different types of preceding infections, anti-neural antibodies and genetic polymorphisms. Optimal treatment of individual patients may depend on the pathogenesis and clinical severity. Patients with severe forms of GBS may possibly need more intensive treatment to recover. Patients with a milder course that fully recover after standard therapy could suffer from possibly more side effects of more aggressive forms of treatment. This could only be possible if there are prognostic models that accurately predict the clinical course in individual patients. Ideally such models should be based on clinical and biological predictors that are strongly associated with disease course and known as early as possible in the acute phase of illness, when treatment with immunomodulatory therapy is most effective. Prognostic models could help to guide selective trials in specific GBS subtypes. Because of this it will be possible to treat GBS with more effective and more individual therapy. This study aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease. This information will be used to understand the diversity in clinical presentation and response to treatment of GBS. This information will also be used to develop new prognostic models to predict the clinical course and outcome accurately in individual patients with GBS. To address these research questions it is required to conduct a prospective study with standardized collection of clinical data and biomaterials from a large group of well-defined GBS patients during a long follow-up period. Such an extensive study in a relatively rare disease as GBS can be addressed only by intensive international collaboration.

Methods

Condition: Guillain-Barré Syndrome

Recruitment information

Gender: All

Trial period

2012-2024

Research Categories

Main Subject Area

Fields of Research

External sources

Access at Registry