Clinical trial NCT03136757: Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells
Official title: Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graft Vs Host Disease
Hematopoietic Stem Cells
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: