Study of Periodontitis and Blood Stream Infection in AML... | NCT04858594

Studies
Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy

NCT04858594

Sponsor

Masonic Cancer Center, University of Minnesota

Status

Terminated

Last Update Posted

Apr 11, 2022Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Acute Myeloid Leukemia

Interventions

Planned Chemotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HM2020-37	Other Identifier	University of Minnesota Masonic Cancer Center

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left and research was stopped

Expanded Access Info

Start Date

May 4, 2021Actual

Primary Completion Date

Feb 28, 2022Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

Apr 21, 2021

First Submission Date that Met QC Criteria

Apr 21, 2021

First Posted Date

Apr 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: with Periodontitis		Patients with periodontitis	Other: Planned Chemotherapy
Arm B: without Periodontitis		Patients without periodontitis	Other: Planned Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Planned Chemotherapy	Other	standard oncologic supportive care including antibiotic prophylaxis	Arm A: with Periodontitis Arm B: without Periodontitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Blood stream infections	Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy	Day 28 of chemotherapy

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with Neutropenic fever	Number of participants experiencing Neutropenic fever (NF) by day 28 of chemotherapy	Day 28 of chemotherapy
Number of participants exposed to different antibiotics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study entry is open to adult patients regardless of gender, race or ethnic background. While there will be every effort to seek out and include women and minority patients, the patient population is expected to be similar to that of other relapsed AML studies at the University Of Minnesota

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin Rashidi, MD, PhD	Masonic Cancer Center, University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Masonic Cancer Center, University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D010518	Periodontitis

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Research samples of gingival sulcus fluid, saliva and serum will be collected at baseline. Additionally the blood will be collected weekly through day 28 (or discharge if sooner), and if the patient develops neutropenic fever NF. NF is defined as an oral temperature of ≥100.4°F combined with an absolute neutrophil count (ANC) of ≤0.5x10^9/L^10