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

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

NCT ID: NCT06121765

Condition: CML, Chronic Phase

Conditions: Official terms:
Leukemia, Myeloid, Chronic-Phase
Tyrosine Kinase Inhibitors

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Other
Intervention name: Tyrosine kinase inhibitor
Description: Follow up base metabolic index,lipid profile, HbA1c, thyroid function in CML patients treated with TKI

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: November 1, 2023

Completion date: November 30, 2025

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06121765