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van CCT (UK)

van CCT (UK)

Oral complications of hematopoietic stem cell transplantation

- candidate number23939
- NTR NumberNTR5760
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2016
- Secondary IDsNL 52117.0187 METC
- Public TitleOral complications of hematopoietic stem cell transplantation
- Scientific TitleThe influence of the oral microbiome and salivary proteome on oral complications in hematopoietic stem cell transplantation recipients:H-OME study
- hypothesisThe 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)
- Healt Condition(s) or Problem(s) studiedStem cell transplantation , Mucositis, Periodontal health, Graft-versus-host disease, Dental caries
- Inclusion criteriaAdult hematopoietic stem cell recipients
- Exclusion criteriaPatients unable to give their informed consent
Patients younger than 18 years
Mismatched allogeneic transplantations
Caries study: edentulous patients
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2015
- planned closingdate1-jan-2021
- Target number of participants102
- InterventionsNot applicable
- Primary outcomeIncidence, 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 outcomeIdentification 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
- TimepointsBefore, during and up to 18 months following hematopoietic stem cell transplantation
- Trial web siteNot applicable
- statusrecruitement status not public
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA), Academic Medical Center (AMC), Amsterdam, Radboud University Medical Center Nijmegen, Nijmegen Carolina's Medical Center, Charlotte, NC, USA , Sahlgrenska University Hospital Gothenburg, Sweden
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsA number of publications in peer reviewed scientific journals is planned to report the findings of this study
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD16-feb-2016 - 28-mei-2016

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