Status:
TERMINATED
Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
Detailed Description
Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy....
Eligibility Criteria
Inclusion
- Age \>18 years
- Diagnosis of AML, new diagnosis or relapsed/refractory disease
- Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer
- Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy
- Written informed consent prior to performance of any research related activities
Exclusion
- Unstable for transfer to the School of Dentistry
- Fever at the time of enrollment
- Documented blood stream infection at the time of enrollment
- Inherited bleeding diathesis
- Periodontitis requiring treatment before starting chemotherapy
- ANC \<0.5 x 10\^9/L at the time of enrollment
- Unstable for transfer to the School of Dentistry
- Fever at the time of enrollment
- Documented blood stream infection at the time of enrollment
- Inherited bleeding diathesis
- Periodontitis requiring treatment before starting chemotherapy
Key Trial Info
Start Date :
May 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04858594
Start Date
May 4 2021
End Date
February 28 2022
Last Update
April 11 2022
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455