NCT06469047

Brief Summary

Patients diagnosed with acute myeloid leukemia in the Second Hospital of Shanxi Medical University were selected and divided into the newly diagnosed group, the relapsed group, the complete remission group as the experimental group, and the healthy physical examination subjects as the control group. The relationship between IL-1β, catecholamine and norkephalin in peripheral blood of the experimental group and the control group was observed. According to the literature, the experimental group was significantly higher than the control group. In the experimental group, the newly diagnosed group was higher than the relapse group, and the relapse group was higher than the complete remission group, and the correlation was positive, and the difference was statistically significant.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 16, 2024

Last Update Submit

June 16, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • N/OFQ

    Serum N/OFQ levels

    24 hours

  • IL-1β

    Serum IL-1β levels

    24 hours

  • NE

    Serum NE levels

    24 hours

Study Arms (4)

the newly diagnosed group

Diagnostic Test: Enzyme-linked immunosorbent assay

the relapsed group

Diagnostic Test: Enzyme-linked immunosorbent assay

the complete remission group

Diagnostic Test: Enzyme-linked immunosorbent assay

the control group

Diagnostic Test: Enzyme-linked immunosorbent assay

Interventions

Serum N/OFQ , IL-1β and NE levels were detected.

the complete remission groupthe control groupthe newly diagnosed groupthe relapsed group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the Second Hospital of Shanxi Medical University from June 2022 to November 2023

You may qualify if:

  • In accordance with adult acute myeloid leukemia (non-acute promyelocytic leukemia)The diagnostic criteria for AML in the Chinese Diagnosis and Treatment Guidelines (2017 edition); ②Leukocyte count ≤ 25×109/L;
  • No treatment has been received in the past 6 months.
  • None of the candidates are related and known this study, and sign the informed consent.

You may not qualify if:

  • Patients who are allergic to the drugs used in this study;
  • People with mental illness or cognitive impairment;
  • Patients with infectious diseases; ④Patients with severe heart, liver, kidney and other organ function lesions; ⑤ Combined with other malignant swelling. The tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 16, 2024

First Posted

June 21, 2024

Study Start

June 20, 2024

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations