Prognostic Impacts of Lipid Profile and BMI in Adult AML

NCT07143877 | Not Yet Recruiting

• 1 other identifier: 04-2025-201323
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the changes in lipid profile parameters (total cholesterol, triglycerides, HDL-C, and LDL-C) in adult AML patients before and after intensive induction chemotherapy. The main questions it aims to answer are:

• Are there correlations between metabolic changes (in lipid profile and BMI) and treatment outcomes, including remission status and incidence of chemotherapy-related complications?
• Can the baseline lipid profile and BMI serve as prognostic markers for response to induction chemotherapy.? Participants will be observed before and after induction chemotherapy regarding their lipid profile, and BMI, observing any correlations between the different results with any complications, and with remission status.

Conditions

AML (Acute Myeloid Leukemia); BMI; Lipid Profile; Induction Chemotherapy

Keywords

AML; BMI; Lipid profile; Adult; Induction chemotherapy

Outcome Measures

Primary Outcomes (2)

• Changes in lipid profile

  Observing changes of lipid profile (total cholesterol, triglycerides, HDL-C, LDL-C) measured at baseline and after completion of induction therapy

  Pre-induction to post-induction (day 28-35).

• Changes in Body Mass Index

  Observing changes of Body Mass Index (measured as weight in kilograms divided by squared height in meters) measured at baseline and after completion of induction therapy

  Pre-induction to post-induction (day 28-35)

Secondary Outcomes (2)

• Association of lipid profile changes with treatment response

  Pre-induction to post-induction (day 28-35).

• Association of Body Mass Index changes with treatment response

  Pre-induction to post-induction (day 28-35)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients(≥18yearsold) newly diagnosed with AML.

You may qualify if:

• Adult patients (≥18yearsold) newly diagnosed with AML.
• Patients eligible for intensive induction chemotherapy.
• Patients who have given informed consent to participate in the study.

You may not qualify if:

• Patients with secondary or relapsed AML.
• Patients currently using lipid-lowering medications (e.g., statins).
• Patients with known endocrine or metabolic disorders affecting BMI or lipid profile (e.g., uncontrolled diabetes, hypothyroidism, Cushing's syndrome).
• Pregnant or lactating women.
• Patients unwilling or unable to complete the study protocol.
• Patients with M3 subtype of AML.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Hospitals

Asyut, Asyut Governorate, 71511, Egypt

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mohammad S Mohammad, MBBS

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad S Mohammad, MBBS

CONTACT

+201095027359; mohamed.17289893@med.aun.edu.eg

Amira H Abdel Aziz, MD

CONTACT

+201092094687; amirahassan13@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 35 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of internal medicine department

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 27, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)