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

Graft Vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136757
• Other study ID #: PI2016_843_0016
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2017
• Last updated: July 19, 2017
• Start date: August 20, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Jean-Pierre MAROLLEAU, PhD
• Phone: +33322455914
• Email: marolleau.jean-pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Vs Host Disease
• Hematopoietic Stem Cells

Intervention

Other:
• Transcriptomic analysis of GVHD biopsies
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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response		3 months