Graft Vs Host DiseaseNCT03136757
Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells
An observational study of Graft Vs Host Disease and Hematopoietic Stem Cells, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Vs Host Disease, Hematopoietic Stem Cells
- What is being tested?
- Transcriptomic analysis of GVHD biopsies
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2016to 16 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- Transcriptomic analysis of GVHD biopsies
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcriptomic analysis of GVHD biopsiesOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start22 Sep 2016 (estimated)
- Primary completion22 Sep 2016 (estimated)
- Study completion16 Oct 2018
Why it stopped: Financing problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136757
- Sponsor's protocol ID
- PI2016_843_0016
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells
- ClinicalTrials.gov ID
- NCT03136757
- Acronym / sponsor ID
- PI2016_843_0016
- Conditions
- Graft Vs Host Disease, Hematopoietic Stem Cells
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Financing problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Sep 2016 (estimated)
- Primary completion
- 22 Sep 2016 (estimated)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcriptomic analysis of GVHD biopsiesThe 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 | Other | – |
Primary outcome
Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Vs Host Disease and Hematopoietic Stem Cells, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.