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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03136757
Other study ID # PI2016_843_0016
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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