Myelo Dysplastic SyndromeNCT07210034
What is the Prognostic Value of HALP Score, Monocytopenia, Hypofibrinogenemia, and AST/ALT Ratio in Patients With Myelodysplastic Syndromes
An observational study of Myelo Dysplastic Syndrome, run by Assiut University.
Trial summary
to investigate prognostic significance of many factors in MDS including HALP score ( haemoglobin level, albumin level, lymphocyte, platelets), monocytopenia, hyperfibrinogenemia and AST/ALT ratio in patients with MDS at Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelo Dysplastic Syndrome
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years old) diagnosed with MDS according to WHO criteria
Who may be able to join
- • Adults (≥18 years old) diagnosed with MDS according to WHO criteria
- Availability of complete medical records including laboratory data for hemoglobin, albumin, lymphocyte count, platelet count, monocyte count, fibrinogen level, AST and ALT
- Patients who were followed for at least 12 months post-diagnosis or until death
Who cannot join
- Patients with active infections, liver cirrhosis, chronic inflammatory diseases, or concurrent malignancies at time of diagnosis
- Incomplete laboratory or clinical data
- Patients lost to follow-up within less than 3 months of diagnosis
About this study
Official title: Prognostic Value of HALP Score, Monocytopenia, Hypofibrinogenemia, and AST/ALT Ratio in Patients With Myelodysplastic Syndromes at Assiut University Hospital.
to investigate prognostic significance of many factors in MDS including HALP score ( haemoglobin level, albumin level, lymphocyte, platelets), monocytopenia, hyperfibrinogenemia and AST/ALT ratio in patients with MDS at Assiut University Hospital.
And to study overall survival and leukemia free survival rates in MDS patients.
Read the detailed description
Frequently seen in advanced age, myelodysplastic syndromes (MDS) are a heterogeneous clonal stem cell disorders characterized by ineffective hematopoiesis and having a risk of progression to acute myeloid leukemia (AML). The clinical course of MDS varies considerably, and most patients cannot tolerate intensive treatment approaches due to their advanced age. Accurate diagnosis and reliable prognostic assessment are of critical importance for making individualized clinical decisions in patients with MDS(2). Therefore, prognostic parameters and/or prognostic scoring systems have been developed to distinguish between patient groups differing in median survival time. An ideal prognostic scoring system should contain merely independent prognostic parameters, and the limits of these parameters should be validated, easily identifiable at diagnosis, and cost-effective. The international prognostic scoring system (IPSS), the revised IPSS (IPSS-R), and the World Health Organization (WHO) prognostic scoring system [WPSS] are the most commonly utilized prognostic models (3,4). However, it is considered that many factors, except for the variables in these systems, may also affect the prognosis of MDS5. Immune response and Inflammatory cells have been defined as very important parameters in cancer survival rate(6). In several recent studies, peripheral blood cells, including absolute lymphocyte count (ALC), monocytes, and platelets (Plt), have been reported to be related to higher mortality rates in lymphoma patients(7,8 ) . In recent years, many combinations of infammatory parameters, such as neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, and lymphocyte-monocyte ratio have been used to predict the prognosis in patients with oncological and hematological malignancies (9-11). Nutritional status has also been emphasized in various studies as an important factor affecting the prognosis(11-13). Previous studies have defined a new infammatory index called the hemoglobin, albumin, lymphocyte, and platelet (HALP) score, which is effective in the prognosis of those with kidney, bladder, stomach, small-cell lung, and prostate cancers(14-17). The HALP score is calculated using four laboratory markers (hemoglobin, albumin, lymphocyte, and platelet), which are the biomarkers of nutrition and Inflammation status. In the field of hematology, the prognostic efficiency of the HALP score has been evaluated in a limited number of studies, including in diffuse large B-cell lymphoma and multiple myeloma (18,19). Based on the literature, however, there are no studies evaluating the relationship between the HALP score and the prognosis of MDS patients. Also , numerous promising biomarkers have been evaluated as potential prognosis predictors for MDS. For instance, low absolute lymphocyte count (ALC) and absolute monocyte count (AMC) levels, decreased serum ApoA1 levels, as well as an increase in the number of mature monocytes in the bone marrow can predict poor prognosis in MDS.(6-9 )However, none of these markers have been adopted into IPSS-R. In recent years, it has also been reported that high FIB is a poor prognostic factor in some tumors.(10-12 )However, evidence of the role of FIB in MDS is lacking. In addition, AST/ALT ratio could be a simple and economic prognostic indicator for MDS and be used as a supplement to IPSS-R, especially when lacking of karyotype or mutation data.
- Conditions
- Myelo Dysplastic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostic significance of many factors in MDS
to investigate prognostic significance of many factors in MDS including HALP score ( haemoglobin level, albumin level, lymphocyte, platelets), in patients with MDS at Assiut University Hospital HALP : a derived value from a formula: Hemoglobin (g/L) × Albumin (g/L) × Lymphocytes (/L) / Platelets (/L)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelo Dysplastic SyndromeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Merzek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210034
- Sponsor's protocol ID
- HALP-MDS
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of HALP Score, Monocytopenia, Hypofibrinogenemia, and AST/ALT Ratio in Patients With Myelodysplastic Syndromes at Assiut University Hospital.
- ClinicalTrials.gov ID
- NCT07210034
- Acronym / sponsor ID
- HALP-MDS
- Conditions
- Myelo Dysplastic Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Oct 2025 (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.
to investigate prognostic significance of many factors in MDS including HALP score ( haemoglobin level, albumin level, lymphocyte, platelets), monocytopenia, hyperfibrinogenemia and AST/ALT ratio in patients with MDS at Assiut University Hospital.
And to study overall survival and leukemia free survival rates in MDS patients.
Detailed description
Frequently seen in advanced age, myelodysplastic syndromes (MDS) are a heterogeneous clonal stem cell disorders characterized by ineffective hematopoiesis and having a risk of progression to acute myeloid leukemia (AML). The clinical course of MDS varies considerably, and most patients cannot tolerate intensive treatment approaches due to their advanced age. Accurate diagnosis and reliable prognostic assessment are of critical importance for making individualized clinical decisions in patients with MDS(2). Therefore, prognostic parameters and/or prognostic scoring systems have been developed to distinguish between patient groups differing in median survival time. An ideal prognostic scoring system should contain merely independent prognostic parameters, and the limits of these parameters should be validated, easily identifiable at diagnosis, and cost-effective. The international prognostic scoring system (IPSS), the revised IPSS (IPSS-R), and the World Health Organization (WHO) prognostic scoring system [WPSS] are the most commonly utilized prognostic models (3,4). However, it is considered that many factors, except for the variables in these systems, may also affect the prognosis of MDS5. Immune response and Inflammatory cells have been defined as very important parameters in cancer survival rate(6). In several recent studies, peripheral blood cells, including absolute lymphocyte count (ALC), monocytes, and platelets (Plt), have been reported to be related to higher mortality rates in lymphoma patients(7,8 ) . In recent years, many combinations of infammatory parameters, such as neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, and lymphocyte-monocyte ratio have been used to predict the prognosis in patients with oncological and hematological malignancies (9-11). Nutritional status has also been emphasized in various studies as an important factor affecting the prognosis(11-13). Previous studies have defined a new infammatory index called the hemoglobin, albumin, lymphocyte, and platelet (HALP) score, which is effective in the prognosis of those with kidney, bladder, stomach, small-cell lung, and prostate cancers(14-17). The HALP score is calculated using four laboratory markers (hemoglobin, albumin, lymphocyte, and platelet), which are the biomarkers of nutrition and Inflammation status. In the field of hematology, the prognostic efficiency of the HALP score has been evaluated in a limited number of studies, including in diffuse large B-cell lymphoma and multiple myeloma (18,19). Based on the literature, however, there are no studies evaluating the relationship between the HALP score and the prognosis of MDS patients. Also , numerous promising biomarkers have been evaluated as potential prognosis predictors for MDS. For instance, low absolute lymphocyte count (ALC) and absolute monocyte count (AMC) levels, decreased serum ApoA1 levels, as well as an increase in the number of mature monocytes in the bone marrow can predict poor prognosis in MDS.(6-9 )However, none of these markers have been adopted into IPSS-R. In recent years, it has also been reported that high FIB is a poor prognostic factor in some tumors.(10-12 )However, evidence of the role of FIB in MDS is lacking. In addition, AST/ALT ratio could be a simple and economic prognostic indicator for MDS and be used as a supplement to IPSS-R, especially when lacking of karyotype or mutation data.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years old) diagnosed with MDS according to WHO criteria
Key inclusion criteria (3 listed)
- • Adults (≥18 years old) diagnosed with MDS according to WHO criteria
Key exclusion criteria (3 listed)
- Patients with active infections, liver cirrhosis, chronic inflammatory diseases, or concurrent malignancies at time of diagnosis
- Incomplete laboratory or clinical data
- Patients lost to follow-up within less than 3 months of diagnosis
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
prognostic significance of many factors in MDS
Time frame: Two years
to investigate prognostic significance of many factors in MDS including HALP score ( haemoglobin level, albumin level, lymphocyte, platelets), in patients with MDS at Assiut University Hospital HALP : a derived value from a formula: Hemoglobin (g/L) × Albumin (g/L) × Lymphocytes (/L) / Platelets (/L)
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 7 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelo Dysplastic Syndrome, 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 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: opening soon, as of the sponsor's last update on 7 Oct 2025. 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?
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?
prognostic significance of many factors in MDS (time frame: Two 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 7 Oct 2025.