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

NCT ID: NCT03136757

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2017-10-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Pierre MAROLLEAU, PhD

Role: CONTACT

marolleau.jean-pierre@chu-amiens.fr

+33322455914

Facility Contacts

Jean-Pierre MAROLLEAU, PhD

Role: primary

marolleau.jean-pierre@chu-amiens.fr

+33322455914

Other Identifiers

PI2016_843_0016

Identifier Type: -

Identifier Source: org_study_id