Clinical trial NCT06121765: Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI
Official title: Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CML, Chronic Phase
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic myeloid leukemia (CML), a clonal hematopoietic stem cell malignancy, is characterized by unique translocation leading to the formation of the Philadelphia chromo- some.1 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.2,3 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: