Biomarkers for Acute Graft-versus-host Disease

Acute GVH Disease Clinical Trial

— PLASMA-INCA  

Official title:

Diagnostic and Prognostic Biomarkers for Acute Graft-versus-host Disease: a Prospective Single Centre Biological Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02254798
• Other study ID #: NI13015 PLASMA-INCA
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 29, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie Robin, MD, PhD
• Phone: 33142494724
• Email: marie.robin[@]sls.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Observational

Clinical Trial 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

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 and/or 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 0.05, 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients receiving an allogeneic transplant

• informed consent signed

Exclusion Criteria:

• patient refusal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute GVH Disease
• Graft vs Host Disease

Intervention

Other:
• no intervention
this is a non interventional study

Locations

Country	Name	City	State
France	Hôpital Saint-Louis	Paris
France	Hôpital Saint-Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with an Acute Graft-versus-Host disease	Evaluation of fecal and plasmatic markers as diagnostic markers of GVHD	The 6 first months after transplantation	No
Primary	Number of patients with an Acute Graft-versus-Host disease refractory to steroids	to evaluate the potential of these markers as risk factors for steroid-refractory acute GVHD occurrence	14 days after acute graft-versus-host disease	No