Acute Myeloid LeukemiaNCT07810829
Prognostic Value of CAR, AFR and Ferritin in Non-M3 AML
An observational study of Acute Myeloid Leukemia and Non-M3 Acute Myeloid Leukemia, run by Assiut University.
Trial summary
This prospective cohort study aims to evaluate the prognostic significance of the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin level in newly diagnosed de novo non-M3 acute myeloid leukemia patients at Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Non-M3 Acute Myeloid Leukemia, De Novo Acute Myeloid Leukemia With Multilineage Dysplasia
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- How long will I take part?
- 24 Months
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed de novo non-M3 acute myeloid leukemia patients admitted to the Internal Medicine Department at Assiut University Hospitals.
Who may be able to join
- Age 18 to 65 years
- Newly diagnosed de novo non-M3 acute myeloid leukemia
- Both sexes
- Willingness to provide informed consent
Who cannot join
- - Patient refusal
- Significant cardiac, hepatic, or renal disease
- Diabetes mellitus with polyneuropathy
- Severe organ dysfunction (modified Marshall score ≥ 2)
- History of MDS transformed to AML
- Previous blood transfusions
- Relapsed AML
- Previous exposure to chemotherapy or radiotherapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Prognostic Significance of C-Reactive Protein to Albumin Ratio, Albumin to Fibrinogen Ratio, and Serum Ferritin Level in Newly Diagnosed De Novo Non-M3 Acute Myeloid Leukemia Patients
This prospective cohort study aims to evaluate the prognostic significance of the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin level in newly diagnosed de novo non-M3 acute myeloid leukemia patients at Assiut University Hospitals.
Read the detailed description
Acute myeloid leukemia (AML) is an aggressive hematological malignancy with poor clinical outcomes. Inflammatory and nutritional biomarkers such as the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin have shown potential prognostic value in various malignancies.
This prospective single-center cohort study will include newly diagnosed de novo non-M3 AML patients aged 18 to 65 years. Baseline laboratory parameters including CRP, albumin, fibrinogen, and ferritin will be measured before induction chemotherapy. Patients will be followed for overall survival, event-free survival, and response to induction therapy. The study will assess the association of CAR, AFR, and serum ferritin with clinical outcomes.
- Conditions
- Acute Myeloid Leukemia, Non-M3 Acute Myeloid Leukemia, De Novo Acute Myeloid Leukemia With Multilineage Dysplasia
- Keywords
- Acute myeloid leukemia, C-reactive protein to albumin ratio
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Newly diagnosed de novo non-M3 AML patients | Adult patients aged 18-65 years with newly diagnosed de novo non-M3 acute myeloid leukemia who will receive induction chemotherapy according to institutional protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from the date of AML diagnosis to death from any cause or last follow-up for surviving patients.
Measured: Up to 24 months
Secondary outcomes (5)
Complete remission rate after induction chemotherapy
Proportion of patients achieving complete remission after induction chemotherapy, defined as bone marrow blasts less than 5%, absolute neutrophil count greater than 1.0 × 10⁹/L, platelet count greater than 100 × 10⁹/L, and independence from red cell transfusions.
Measured: Day 28 after induction chemotherapy
Event-free survival
Time from diagnosis to the first occurrence of treatment failure, relapse, or death from any cause.
Measured: Up to 24 months
Prognostic value of C-reactive protein-to-albumin ratio (CAR)
Hazard ratio for overall survival and event-free survival according to baseline C-reactive protein-to-albumin ratio (CAR), calculated as CRP (mg/L) divided by serum albumin (g/L), using Cox proportional hazards regression.
Measured: Baseline and up to 24 months
Prognostic value of albumin-to-fibrinogen ratio (AFR)
Hazard ratio for overall survival and event-free survival according to baseline albumin-to-fibrinogen ratio (AFR), calculated as plasma fibrinogen concentration (g/L) divided by serum albumin concentration (g/L), using Cox proportional hazards regression.
Measured: Baseline and up to 24 months
Prognostic value of serum ferritin
Hazard ratio for overall survival and event-free survival according to baseline serum ferritin level (ng/mL, corrected if CRP is elevated), using Cox proportional hazards regression.
Measured: Baseline and up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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
- 208 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Salah Noureldin, Assiut University
- Investigators
- Mohamed R Hameed, prof, Study chair, Internal medicine, clinical Hematology & bone marrow tramsplant unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810829
- Sponsor's protocol ID
- AML-CAR-AFR-Ferritin-Assiut-20
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Li Y, Zeng L, Li X, Chen N, Bai S, He H, Wang Q, Zhang C. A Review on Mechanochemistry: Approaching Advanced Energy Materials with Greener Force. Adv Mater. 2022 Nov;34(46):e2108327. doi: 10.1002/adma.202108327. Epub 2022 Mar 20.
PubMed 35015320Etra JW, Canner JK, Aslam U, Nasr IW. Penetrating Trauma in Baltimore: An Analysis of the Effect of a Rise in Localized Violence by Age Group. J Surg Res. 2021 Jun;262:38-46. doi: 10.1016/j.jss.2020.11.083. Epub 2021 Feb 3.
PubMed 33545620Quan DH, Counoupas C, Nagalingam G, Pinto R, Petrovsky N, Britton WJ, Triccas JA. Advax adjuvant formulations promote protective immunity against aerosol Mycobacterium tuberculosis in the absence of deleterious inflammation and reactogenicity. Vaccine. 2021 Apr 1;39(14):1990-1996. doi: 10.1016/j.vaccine.2021.02.041. Epub 2021 Mar 11.
PubMed 33714652Yoshie H, Sedukhina AS, Minagawa K, Oda K, Ohnuma S, Yanagisawa N, Maeda I, Takagi M, Kudo H, Nakazawa R, Sasaki H, Kumai T, Chikaraishi T, Sato K. A bioinformatics-to-clinic sequential approach to analysis of prostate cancer biomarkers using TCGA datasets and clinical samples: a new method for precision oncology? Oncotarget. 2017 Aug 24;8(59):99601-99611. doi: 10.18632/oncotarget.20448. eCollection 2017 Nov 21.
PubMed 29245927
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Significance of C-Reactive Protein to Albumin Ratio, Albumin to Fibrinogen Ratio, and Serum Ferritin Level in Newly Diagnosed De Novo Non-M3 Acute Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT07810829
- Acronym / sponsor ID
- AML-CAR-AFR-Ferritin-Assiut-20
- Conditions
- Acute Myeloid Leukemia, Non-M3 Acute Myeloid Leukemia, De Novo Acute Myeloid Leukemia With Multilineage Dysplasia
- Keywords
- Acute myeloid leukemia, C-reactive protein to albumin ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 9 Sep 2026 (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.
This prospective cohort study aims to evaluate the prognostic significance of the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin level in newly diagnosed de novo non-M3 acute myeloid leukemia patients at Assiut University Hospitals.
Detailed description
Acute myeloid leukemia (AML) is an aggressive hematological malignancy with poor clinical outcomes. Inflammatory and nutritional biomarkers such as the C-reactive protein-to-albumin ratio (CAR), albumin-to-fibrinogen ratio (AFR), and serum ferritin have shown potential prognostic value in various malignancies.
This prospective single-center cohort study will include newly diagnosed de novo non-M3 AML patients aged 18 to 65 years. Baseline laboratory parameters including CRP, albumin, fibrinogen, and ferritin will be measured before induction chemotherapy. Patients will be followed for overall survival, event-free survival, and response to induction therapy. The study will assess the association of CAR, AFR, and serum ferritin with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Newly diagnosed de novo non-M3 AML patients | – | –Adult patients aged 18-65 years with newly diagnosed de novo non-M3 acute myeloid leukemia who will receive induction chemotherapy according to institutional protocols. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed de novo non-M3 acute myeloid leukemia patients admitted to the Internal Medicine Department at Assiut University Hospitals.
Key inclusion criteria (4 listed)
- Age 18 to 65 years
Key exclusion criteria (8 listed)
- - Patient refusal
- Significant cardiac, hepatic, or renal disease
- Diabetes mellitus with polyneuropathy
- Severe organ dysfunction (modified Marshall score ≥ 2)
- History of MDS transformed to AML
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: Up to 24 months
Time from the date of AML diagnosis to death from any cause or last follow-up for surviving patients.
5 secondary outcomes
Complete remission rate after induction chemotherapy
Time frame: Day 28 after induction chemotherapy
Event-free survival
Time frame: Up to 24 months
Prognostic value of C-reactive protein-to-albumin ratio (CAR)
Time frame: Baseline and up to 24 months
Prognostic value of albumin-to-fibrinogen ratio (AFR)
Time frame: Baseline and up to 24 months
Prognostic value of serum ferritin
Time frame: Baseline and up to 24 months
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 9 Sep 2026.
- Background: PubMed 35015320Liu X, Li Y, Zeng L, Li X, Chen N, Bai S, He H, Wang Q, Zhang C. A Review on Mechanochemistry: Approaching Advanced Energy Materials with Greener Force. Adv Mater. 2022 Nov;34(46):e2108327. doi: 10.1002/adma.202108327. Epub 2022 Mar 20.
- Background: PubMed 33545620Etra JW, Canner JK, Aslam U, Nasr IW. Penetrating Trauma in Baltimore: An Analysis of the Effect of a Rise in Localized Violence by Age Group. J Surg Res. 2021 Jun;262:38-46. doi: 10.1016/j.jss.2020.11.083. Epub 2021 Feb 3.
- Background: PubMed 33714652Quan DH, Counoupas C, Nagalingam G, Pinto R, Petrovsky N, Britton WJ, Triccas JA. Advax adjuvant formulations promote protective immunity against aerosol Mycobacterium tuberculosis in the absence of deleterious inflammation and reactogenicity. Vaccine. 2021 Apr 1;39(14):1990-1996. doi: 10.1016/j.vaccine.2021.02.041. Epub 2021 Mar 11.
- Background: PubMed 29245927Yoshie H, Sedukhina AS, Minagawa K, Oda K, Ohnuma S, Yanagisawa N, Maeda I, Takagi M, Kudo H, Nakazawa R, Sasaki H, Kumai T, Chikaraishi T, Sato K. A bioinformatics-to-clinic sequential approach to analysis of prostate cancer biomarkers using TCGA datasets and clinical samples: a new method for precision oncology? Oncotarget. 2017 Aug 24;8(59):99601-99611. doi: 10.18632/oncotarget.20448. eCollection 2017 Nov 21.
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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.
Mohamed R Hameed, prof study chair
Internal medicine, clinical Hematology & bone marrow tramsplant unit
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Non-M3 Acute Myeloid Leukemia, run by Assiut University.
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 4 inclusion and 8 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Aya s Noureldin, Resident (+20 11 47324230, aya.18323603@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810829, which also lists 4 linked publications.
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 9 Sep 2026.