Relation of C-reactive Protein/ Albumin Ratio and Coagulation Profile in Acute Myeloid Leukemia Patients

January 27, 2025 updated by: shrouk mosallam ahmed khalaf, Assiut University
The investigators will investigate the relation between CAR and coagulation profile in newly diagnosed AMl patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

all cases newly diagnosed with acute myeloid leukemia

Description

Inclusion Criteria:

- all cases newly diagnosed with acute myeloid leukemiain assuit university hospital

Exclusion Criteria:

  1. cases with chronic myeloid leukemia
  2. cases with acute lymphoblasticleukemia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Study complete an average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: sohir kamel, prof, Director

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)

April 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aml and crp/albumin ratio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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