Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02254798
Status:
UNKNOWN
Last Update Posted:
2014-10-02
First Post:
2014-09-17
Brief Title:
Biomarkers for Acute Graft-versus-host Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Diagnostic and Prognostic Biomarkers for Acute Graft-versus-host Disease a Prospective Single Centre Biological Study
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLASMA-INCA
Brief Summary:
Validation of already described biomarkers on acute GVHD prediction and severity Fecal calprotectin and alpha 1 anti-trypsin plasmatic RER3a IL-8 Elafin TNFaR1 IL-2R alpha HGF
Detailed Description:
Description of the project The main objective of this prospective biological single center study non interventional is to identify non invasive biomarkers able to diagnose acute GVHD andor predict outcome of patients with acute GVHD The primary objective of the study is double 1 to evaluate markers as diagnostic markers of GVHD 2 to evaluate the potential of the markers as risk factor for steroid-refractory acute GVHD occurrence Secondary objectives are -to evaluate the markers as risk factors for GVHD -to evaluate the potential of these markers as prognostic factors of 6-month non-relapse mortality in patients with acute GVHD-to evaluate the additional value of the biomarkers to predict GVHD or steroid-refractory GVHD as compared to other known and routinely used risk factors clinical grading system performance status albuminemia Stools and blood will be on day 7 14 21 28 after transplantation and the first day of digestive GVHD Management of patients will not differ from the usual care Fecal calprotectin and alpha 1 anti-trypsin plasmatic RER3a IL-8 Elafin TNFaR1 IL-2R alpha HGF will be measured at each points by ELISA tests 315 patients would be sufficient to estimate the area under the ROC curve with a half-width of the 99 confidence interval of 005 assuming 60 of patients would develop acute GVHD and normally distributed markers The diagnosis and prognosis values will be analyzed separately
Expected results If some biomarkers are found significantly associated with diagnosis or prognosis of acute GVHD they will be compared with the current clinical biological and histological markers Indeed these markers have a clinical potential impact only if they give similar or better information than routine currently available markers ie clinical GVHD grading system performance status gut endoscopy and histology The non-invasivity of these biomarkers should also be taken into account in comparison to histology
Identification of diagnostic markers will avoid useless treatment with high dose corticosteroids in patients without GVHD Identification of prognostic markers will comfort the decision of a second-line treatment sooner than usually ie at GVHD onset Indeed the onset of a second-line treatment after a steroid-refractory GVHD varies from 3 to 21 days depending on clinical evolution of patients If some prognostic markers are available at diagnosis delay in second-line treatment can be shortened and the patient can consequently have an increased chance to response to an early treatment
Identification of prognostic markers will also guide the corticosteroids decrease in patients with good prognosis GVHD
Expected results If some biomarkers are found significantly associated with diagnosis or prognosis of acute GVHD they will be compared with the current clinical biological and histological markers Indeed these markers have a clinical potential impact only if they give similar or better information than routine currently available markers ie clinical GVHD grading system performance status gut endoscopy and histology The non-invasivity of these biomarkers should also be taken into account in comparison to histology
Identification of diagnostic markers will avoid useless treatment with high dose corticosteroids in patients without GVHD Identification of prognostic markers will comfort the decision of a second-line treatment sooner than usually ie at GVHD onset Indeed the onset of a second-line treatment after a steroid-refractory GVHD varies from 3 to 21 days depending on clinical evolution of patients If some prognostic markers are available at diagnosis delay in second-line treatment can be shortened and the patient can consequently have an increased chance to response to an early treatment
Identification of prognostic markers will also guide the corticosteroids decrease in patients with good prognosis GVHD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None