AMLNCT06714071
Relation of C-reactive Protein/ Albumin Ratio and Coagulation Profile in Acute Myeloid Leukemia Patients
An observational study of AML, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators will investigate the relation between CAR and coagulation profile in newly diagnosed AMl patients Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- AML
- What is being tested?
- CRP and Albumin and coagulation profile
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all cases newly diagnosed with acute myeloid leukemia
Who may be able to join
- all cases newly diagnosed with acute myeloid leukemiain assuit university hospital
Who cannot join
- cases with chronic myeloid leukemia
- cases with acute lymphoblasticleukemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The investigators will investigate the relation between CAR and coagulation profile in newly diagnosed AMl patients
Read the detailed description
Acute myeloid leukaemia (AML) is an aggressive haematological malignancy with a high degree of heterogeneity. It has long been recognized that systemic inflammation is associated with tumorigenesis it revealed that elevated C-reactive protein levels were associated with worse survival outcomes in patients with various types of cancer, including hematologic malignancies. Serum albumin is a measure of an individual's nutritional status. Systemic inflammation can reduce serum albumin concentrations by increasing capillary permeability . The ratio of CRP to albumin (CAR) is a useful score based on inflammation and nutrition, reflecting not only systemic inflammation status but also nutritional status. The Glasgow prognostic score (GPS) and modified GPS (mGPS), determined by the serum CRP and albumin levels, have been proposed as prognostic indicators for AML patients. However, the clinical correlations of CAR and its prognostic value in AML patients have not yet been clarified. Abnormalities of hemostasis can occur in leukemia in the form of disseminated intravascular coagulation(DIC), coagulation protein defect and primary fibrinolysis . Clinically, Types of acute myeloid leukemia like acute promyelocyticleukemia has a high frequency of haemorrhage due to disseminated intravascular coagulation (DIC), which contributes to the high mortality rate of this disease . Therefore, the investigators will investigate CAR its relation with inflammatory response and coagulation profile levels in newly diagnosed acute myeloid leukemia and after 3 month follow up to compare their level and the relation between .
- Conditions
- AML
- Being tested
- CRP and Albumin and coagulation profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP and Albumin and coagulation profileDiagnostic test
CRP and Albumin and coagulation profile
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between C- reactive protein and coagulation profile in AML patients
the investigators will investigate the correlation between CAR and coagulation profile in newly diagnosed AMl patients by measure crp and coagulation profile in newly diagnosed patient and up to 3 month follow up
Measured: Study complete an average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study startApr 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shrouk mosallam ahmed khalaf, Assiut University
- Investigators
- sohir kamel, prof, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714071
- Sponsor's protocol ID
- aml and crp/albumin ratio
- Status last verified
- Jan 2025
- First submitted
- 8 Nov 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of C-reactive Protein/ Albumin Ratio and Coagulation Profile in Acute Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT06714071
- Acronym / sponsor ID
- aml and crp/albumin ratio
- Conditions
- AML
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 3 Dec 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.
The investigators will investigate the relation between CAR and coagulation profile in newly diagnosed AMl patients
Detailed description
Acute myeloid leukaemia (AML) is an aggressive haematological malignancy with a high degree of heterogeneity. It has long been recognized that systemic inflammation is associated with tumorigenesis it revealed that elevated C-reactive protein levels were associated with worse survival outcomes in patients with various types of cancer, including hematologic malignancies. Serum albumin is a measure of an individual's nutritional status. Systemic inflammation can reduce serum albumin concentrations by increasing capillary permeability . The ratio of CRP to albumin (CAR) is a useful score based on inflammation and nutrition, reflecting not only systemic inflammation status but also nutritional status. The Glasgow prognostic score (GPS) and modified GPS (mGPS), determined by the serum CRP and albumin levels, have been proposed as prognostic indicators for AML patients. However, the clinical correlations of CAR and its prognostic value in AML patients have not yet been clarified. Abnormalities of hemostasis can occur in leukemia in the form of disseminated intravascular coagulation(DIC), coagulation protein defect and primary fibrinolysis . Clinically, Types of acute myeloid leukemia like acute promyelocyticleukemia has a high frequency of haemorrhage due to disseminated intravascular coagulation (DIC), which contributes to the high mortality rate of this disease . Therefore, the investigators will investigate CAR its relation with inflammatory response and coagulation profile levels in newly diagnosed acute myeloid leukemia and after 3 month follow up to compare their level and the relation between .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all cases newly diagnosed with acute myeloid leukemia
Key inclusion criteria (1 listed)
- all cases newly diagnosed with acute myeloid leukemiain assuit university hospital
Key exclusion criteria (2 listed)
- cases with chronic myeloid leukemia
- cases with acute lymphoblasticleukemia
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 |
|---|---|---|
| CRP and Albumin and coagulation profileCRP and Albumin and coagulation profile | Diagnostic test | – |
Primary outcome
Correlation between C- reactive protein and coagulation profile in AML patients
Time frame: Study complete an average 2 years
the investigators will investigate the correlation between CAR and coagulation profile in newly diagnosed AMl patients by measure crp and coagulation profile in newly diagnosed patient and up to 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
sohir kamel, prof study director
Director
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 Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shrouk mosallam, master (01014396113, shrouqmosllam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between C- reactive protein and coagulation profile in AML patients (time frame: Study complete an average 2 years). 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 28 Jan 2025.