Chronic Graft Versus Host DiseaseTEP-GVHNCT02352064
Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH)
A study testing PET (18-FDG) in people with Chronic Graft Versus Host Disease, run by University Hospital, Caen at 1 site in France.
Trial summary
Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- PET (18-FDG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2018
- Phase
- Interventional
- 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
Who may be able to join
- adult >18 years
- Signed informed consent
- subject covered by a social security system
- Absence of contraindication to PET (18F-FDG)
- Allogeneic stem cell transplantation
Who cannot join
- Adult patient under tutelage.
- Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
- Age<18 years
- Evolutive infectious disease
- glycemia >10mmol/L
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Caen, 14000
Sylvain P Chantepie, MD, +33231272073, chantepie-s@chu-caen.fr
Sylvain P Chantepie, MD
About this study
Official title: EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)
Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.
PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.
Read more
Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.
The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.
Read the detailed description
Patients will have PET/CT at day 150+/-15d post-hematopoietic stem cell transplantation (HSCT)
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- PET (18-FDG)
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET (18-FDG)Procedure or surgery
Every patient will have a PET
| Study group | Role | What they receive |
|---|---|---|
| PET-CT at day 150+/-15 days | Experimental | Patient will have PET (18-FDG) following allogeneic stem cell transplantation Receives: Procedure: PET (18-FDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
Presence of pathological 18-FDG uptakes on PET-CT examination in allografted patient compared with standard tests (clinical examination score GVHD, as defined by the NI (with or without targeted organ biopsy) Patient with negative PET-CT and without GVHD signs (NIH classification according to Filipovitch et al) are considered as true negative. Patient with positive PET-CT without GVHD signs are considered as false positive. Patient with clinical GVHD and negative PET-CT are considered as falsse negative and patients with clinical GVHD and positive PET-CT are true positive. The follow-up will determine if PET-CT is positive before the onset of clinical signs of GVHD.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352064
- Sponsor's protocol ID
- 2014-A00724-43
- Acronym
- TEP-GVH
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)
- ClinicalTrials.gov ID
- NCT02352064
- Acronym / sponsor ID
- TEP-GVH / 2014-A00724-43
- Conditions
- Chronic Graft Versus Host Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.
PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.
Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.
The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.
Detailed description
Patients will have PET/CT at day 150+/-15d post-hematopoietic stem cell transplantation (HSCT)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT at day 150+/-15 days | Experimental | Procedure: PET (18-FDG)Patient will have PET (18-FDG) following allogeneic stem cell transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult >18 years
- Signed informed consent
- subject covered by a social security system
- Absence of contraindication to PET (18F-FDG)
- Allogeneic stem cell transplantation
Key exclusion criteria (5 listed)
- Adult patient under tutelage.
- Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
- Age<18 years
- Evolutive infectious disease
- glycemia >10mmol/L
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 |
|---|---|---|
| PET (18-FDG)Every patient will have a PET | Procedure or surgery | PET-CT at day 150+/-15 days |
Primary outcome
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
Time frame: 5 months
Presence of pathological 18-FDG uptakes on PET-CT examination in allografted patient compared with standard tests (clinical examination score GVHD, as defined by the NI (with or without targeted organ biopsy) Patient with negative PET-CT and without GVHD signs (NIH classification according to Filipovitch et al) are considered as true negative. Patient with positive PET-CT without GVHD signs are considered as false positive. Patient with clinical GVHD and negative PET-CT are considered as falsse negative and patients with clinical GVHD and positive PET-CT are true positive. The follow-up will determine if PET-CT is positive before the onset of clinical signs of GVHD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET (18-FDG) in people with Chronic Graft Versus Host Disease, run by University Hospital, Caen 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain P Chantepie, MD (+33231272073, chantepie-s@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care (time frame: 5 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 1 Feb 2017.