AMLRBSNAAMCLNCT06469047
Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia
An observational study of AML, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- AML
- What is being tested?
- Enzyme-linked immunosorbent assay
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients in the Second Hospital of Shanxi Medical University from June 2022 to November 2023
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
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.
- Conditions
- AML
- Being tested
- Enzyme-linked immunosorbent assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme-linked immunosorbent assayDiagnostic test
Serum N/OFQ , IL-1β and NE levels were detected.
| Study group | Role | What they receive |
|---|---|---|
| the newly diagnosed group | Not described Receives: Diagnostic Test: Enzyme-linked immunosorbent assay | |
| the relapsed group | Not described Receives: Diagnostic Test: Enzyme-linked immunosorbent assay | |
| the complete remission group | Not described Receives: Diagnostic Test: Enzyme-linked immunosorbent assay | |
| the control group | Not described Receives: Diagnostic Test: Enzyme-linked immunosorbent assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
N/OFQ
Serum N/OFQ levels
Measured: 24 hours
IL-1β
Serum IL-1β levels
Measured: 24 hours
NE
Serum NE levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469047
- Sponsor's protocol ID
- Hanyi20240408
- Acronym
- RBSNAAMCL
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia
- ClinicalTrials.gov ID
- NCT06469047
- Acronym / sponsor ID
- RBSNAAMCL / Hanyi20240408
- Conditions
- AML
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the Second Hospital of Shanxi Medical University from June 2022 to November 2023
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- Patients who are allergic to the drugs used in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzyme-linked immunosorbent assaySerum N/OFQ , IL-1β and NE levels were detected. | Diagnostic test | the complete remission group, the control group, the newly diagnosed group, the relapsed group |
Primary outcome
N/OFQ
Time frame: 24 hours
Serum N/OFQ levels
IL-1β
Time frame: 24 hours
Serum IL-1β levels
NE
Time frame: 24 hours
Serum NE levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N/OFQ (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.