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THE ORAL CAVITY AS A SOURCE OF FEBRILE NEUTROPENIA

Recruiting
Conditions
Febrile neutropeniaDental focus/fociFebriele neutropenieDentogeen focus/foci
Registration Number
NL-OMON28600
Lead Sponsor
Academic Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

Diagnosed with a solid cancer, lymphoma or multiple myeloma

- Planned treatment with myelosuppressive chemotherapy with FN risk of 10%-20% (with or without targeted therapies or hormonal therapy)

Exclusion Criteria

- Patients unable to give written informed consent

- Patients <18 years

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To identify oral/dental foci prior to the start of chemotherapy and to determine whether these are associated with the development of FN, bacteremia and/or SIRS/sepsis
Secondary Outcome Measures
NameTimeMethod
To assess whether oral/dental foci are associated with the incidence and severity of OM <br /><br>To assess whether OM is associated with FN, bacteremia and SIRS/sepsis <br /><br>To document microbiological shifts (bacteria/fungi) in oral rinsing samples taken prior to chemotherapy and during standard care visits thereafter using an innovative open-end technique and to investigate any associations with the development of OM <br /><br>To assess retrospectively whether any microorganisms found in blood samples from patients with FN are (likely) derived from the oral cavity using DNA finger printing techniques and Q-PCR. <br /><br>To explore whether genetic polymorphisms in candidate genes demonstrate an increased risk for the development of severe OM, FN, and SIRS/sepsis <br /><br>Differences in inflammation parameters in peripheral blood at baseline and when presenting with fever and/or mucositis.
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