Biomarkers for Acute Graft-versus-host Disease

NCT ID: NCT02254798

Last Updated: 2014-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

Conditions

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Acute GVH Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transplanted patients

No intervention Prospective registration of patients receiving an allogeneic hematopoietic stem cell transplant

no intervention

Intervention Type OTHER

this is a non interventional study

Interventions

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no intervention

this is a non interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult patients receiving an allogeneic transplant
* informed consent signed

Exclusion Criteria

* patient refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Robin

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint-Louis

Locations

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Hôpital Saint-Louis

Paris, , France

Site Status RECRUITING

Hôpital Saint-Louis

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie Robin, MD, PhD

Role: CONTACT

33142494724

marie-Hélène Schlageter, PHD

Role: CONTACT

Facility Contacts

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Marie Robin, MD, PhD

Role: primary

Marie Robin

Role: primary

Other Identifiers

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NI13015 PLASMA-INCA

Identifier Type: -

Identifier Source: org_study_id

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