Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT04858594
Status:
TERMINATED
Last Update Posted:
2022-04-11
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy
Sponsor:
Masonic Cancer Center, University of Minnesota
Organization:
Study Overview
Official Title:
Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left and research was stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HM2020-37 | OTHER | University of Minnesota Masonic Cancer Center | View |