Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI

Not yet recruiting

• Conditions: CML, Chronic Phase

• Registration Number: NCT06121765
• Lead Sponsor: Assiut University

Brief Summary

Metabolic alternation and clinicohematological characteristic in chronic phase CML in patient treated with TKI

Detailed Description

Chronic myeloid leukemia (CML), a clonal hematopoietic stem cell malignancy, is characterized by unique translocation leading to the formation of the Philadelphia chromo- some.Because of the specific genotype knowledge, tyrosine kinase inhibitors have been used in CML and have significantly improved the prognosis of patients with CML, especially n high-income countries like the United States.Notably, the 5-year survival rates increased from 40% to 90%. So, CML is increasingly seen as a chronic instead of a potentially fatal disease.

Obesity is increasingly prevalent worldwide and is considered o be an important risk factor for adverse outcomes in many cancers.

Obesity is well-known for being associated with metabolic abnormalities like hyperglycemia, hypertension, or dyslipidemia.The metabolic abnormalities and obesity- induced systemic chronic inflammation contribute to tumorigenesis and progression.

Obesity alone may not reflect the actual metabolic health state, and it appears to be more accurate to reclassify patients based on the combination of body mass index (BMI) and metabolic status to further determine the relationship between obesity itself or the combination of metabolic status and prognosis of patients with CML.

Triglyceride-to-high-density lipoprotein cholesterol ratio (TG/HDL-C) has been proposed as a reliable and simple alternative to assess atherogenic index, insulin resistance, and dyslipidemia.\[8\] Furthermore, positive relationships between the TG/HDL-C ratio and various clinical features of many cancers, such as tumor stage and tumor type, have been reported in previous studies.\[9\] These findings warrant further studies to explore TG/ HDL-C ratio with respect to TKI administration in CML and as a factor associated with side effects, and potentially, to assess its role in prognosis.

Study Timeline

• Study First Submitted: 2023-10-29
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08
• Primary Completion: 2025-10-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patient newly diagnosed with CML and received TKI

Exclusion Criteria

• patient previously diagnosed CML and started treatment or in post treatment follow up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of BMI in patient diagnosed CMLm b. S Evaluat BMI in patient newly diagnosed CMLm , Triglyceride-to-High Density Lipoprotein Cholesterol Ratio b. S	Base line	Evaluation of weight in kg and height in meter will be combined to measure BMI in (kg/m2)