Skip to content

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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03136757
Enrollment
0
Registered
2017-05-02
Start date
2016-09-22
Completion date
2018-10-16
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Vs Host Disease, Hematopoietic Stem Cells

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.

Interventions

OTHERTranscriptomic 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026