- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469047
Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia (RBSNAAMCL)
June 16, 2024 updated by: Zheng Guo, Second Hospital of Shanxi Medical University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030001
- Second Hospital of Shanxi Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients in the Second Hospital of Shanxi Medical University from June 2022 to November 2023
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
the control group
|
Serum N/OFQ , IL-1β and NE levels were detected.
|
|
the newly diagnosed group
|
Serum N/OFQ , IL-1β and NE levels were detected.
|
|
the relapsed group
|
Serum N/OFQ , IL-1β and NE levels were detected.
|
|
the complete remission group
|
Serum N/OFQ , IL-1β and NE levels were detected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
N/OFQ
Time Frame: 24 hours
|
Serum N/OFQ levels
|
24 hours
|
|
NE
Time Frame: 24 hours
|
Serum NE levels
|
24 hours
|
|
IL-1β
Time Frame: 24 hours
|
Serum IL-1β levels
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 20, 2024
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 16, 2024
First Submitted That Met QC Criteria
June 16, 2024
First Posted (Actual)
June 21, 2024
Study Record Updates
Last Update Posted (Actual)
June 21, 2024
Last Update Submitted That Met QC Criteria
June 16, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hanyi20240408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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