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

• Conditions: Graft Vs Host Disease; Hematopoietic Stem Cells

• Registration Number: NCT03136757
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21
• Study Start: 2017-08-20
• Primary Completion: 2017-10-20
• Study Completion: 2017-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response	3 months

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France