Biomarkers for Acute Graft-versus-host Disease (PLASMA-INCA)

September 29, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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

Study Type

Observational

Enrollment (Anticipated)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients receiving an allogeneic transplant

Description

Inclusion Criteria:

  • adult patients receiving an allogeneic transplant
  • informed consent signed

Exclusion Criteria:

  • patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transplanted patients
No intervention Prospective registration of patients receiving an allogeneic hematopoietic stem cell transplant
Other: no intervention
this is a non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with an Acute Graft-versus-Host disease
Time Frame: The 6 first months after transplantation
Evaluation of fecal and plasmatic markers as diagnostic markers of GVHD
The 6 first months after transplantation
Number of patients with an Acute Graft-versus-Host disease refractory to steroids
Time Frame: 14 days after acute graft-versus-host disease
to evaluate the potential of these markers as risk factors for steroid-refractory acute GVHD occurrence
14 days after acute graft-versus-host disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie Robin, Hôpital Saint-Louis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI13015 PLASMA-INCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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