No registrations found.
ID
Source
Brief title
Health condition
hematopoietic stem cell transplantation, mucositis, graft versus host disease, caries, periodontitis
stamceltransplantatie, mucositis, graft versus host ziekte, mondgezondheid
Sponsors and support
Academic Medical Center Amsterdam (AMC)
Radboud Universitair Medisch Centrum, Nijmegen
Carolina's Medical Center, Charlotte,NC, USA
Sahlgrenska University Hospital Gothenburg, Sweden
Intervention
Outcome measures
Primary outcome
Incidence, severity and temporal relationship of oral complications and their relationship with the type of conditioning regimen by using questionnaaires and physical examination
Composition of the oral microbiome, salivary output and proteome before, during and after transplant and assessment of any associations between these components of the oral ecosystem and the development of oral complications
Secondary outcome
Identification of other factors than the conditioning regimen to predict oral complications
Genetic polymorphisms involved in mucositis
Impact of oral complications on clinical and economic outcomes
Impact of oral complications on quality of life
Composition of the microbiome and any associations with incidence, severity and duration of oral mucositis and graft versus host disease
The composition of the salivary proteome and incidence and severity of oral mucositis and graft versus host disease
pre-existent periodontal disease and incidence, severity and duration of oral mucositis and graft versus host disease
Background summary
The oral cavity is a common site of acute and long term complications related to hematopoietic stem cell transplantation (HSCT). These complications cause significant morbidity and are associated with decreased quality of life. To date, management strategies for oral complications are mainly palliative and there is a great need for expanding the arsenal of preventative approaches.
Disturbed homeostasis of the oral cavity has been implicated as an important component of the pathogenesis of oral complications. Studies suggest that a less diverse microbiome, salivary output and proteins, and dental health influence the incidence and severity of oral mucositis and graft versus host disease. In addition, oral environment changes associated with graft versus host disease may increase caries risk. The H-OME study will expand the understanding of the role of the oral ecosystem in the onset, progression, and resolvement of these complications related to HSCT. This is attractive since many oral environment factors are modifiable and we anticipate that this knowledge will enable future development of improved and individualized preventative strategies.
Study objective
The oral environment (e.g., the oral microbiome and salivary proteome) contributes to the risk and severity of developing oral and dental complications (e.g., oral mucositis and oral graft versus host disease and dental diseases)
Study design
Before, during and up to 18 months following hematopoietic stem cell transplantation
Intervention
Not applicable
JE Raber-Durlacher
Amsterdam
The Netherlands
j.e.raberdurlacher@amc.uva.nl
JE Raber-Durlacher
Amsterdam
The Netherlands
j.e.raberdurlacher@amc.uva.nl
Inclusion criteria
Adult hematopoietic stem cell recipients
Exclusion criteria
Patients unable to give their informed consent
Patients younger than 18 years
Mismatched allogeneic transplantations
Caries study: edentulous patients
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5645 |
| NTR-old | NTR5760 |
| CCMO | NL52117.018.15 |
| OMON | NL-OMON41813 |