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Clinical Trial Summary

This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.


Clinical Trial 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. Patients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner). Study participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858594
Study type Observational
Source Masonic Cancer Center, University of Minnesota
Contact Armin Rashidi, MD, PhD
Phone 612-625-1110
Email [email protected]
Status Not yet recruiting
Phase
Start date May 1, 2021
Completion date May 1, 2023

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