Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells

NCT03136757 | Unknown

• 1 other identifier: PI2016_843_0016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment. The present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR). However, to date there is no molecular characterization of this manifestation, and therefore no specific treatment. The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed. No transcriptomic analysis has ever been performed on human tissues with GVHD.

Conditions

Graft Vs Host Disease; Hematopoietic Stem Cells

Outcome Measures

Primary Outcomes (1)

• Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response

  3 months

Interventions

Transcriptomic analysis of GVHD biopsies OTHER

The transcriptomic analysis of GVHD biopsies aims at: * to demonstrate an evocative or even specific molecular profile, making the diagnosis of GVHD easier * to identify new intracellular signaling pathways that could lead to new therapeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recovery of fixed and paraffin-embedded biopsy fragments previously performed during the diagnosis of GVHD, not used for routine histological analysis because in excess, and stored in the pathology laboratory

You may qualify if:

• Person aged ≥ 18 years
• Patients who have received an HSC allograft since June 2012
• Having presented a suspicion of cutaneous or digestive GVHD before J100 post-allograft
• Of which the diagnosis was retained by the combination of clinical and histological criteria
• Or whose diagnosis has been reversed by histological analysis, for the reactive / inflammatory biopsies that serve as control
• The diagnosis of which was made between 01/01/2013 and 31/12/2015
• Survived at least 1 month to monitor clinical progress

You may not qualify if:

• Whose biopsy specimens were also the sites of a viral reactivation (EBV, CMV, HHV) that could mimic a GVHD
• Having survived less than 1 month after the diagnosis of GVHD

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Jean-Pierre MAROLLEAU, PhD

CONTACT

+33322455914; marolleau.jean-pierre@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: August 20, 2017
• Primary Completion: October 20, 2017
• Study Completion: October 20, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

FR (1)