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

CML, Chronic Phase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06121765
• Other study ID #: Metabolic alteration in CML
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Noha Rabea, Resident doctor
• Phone: 01126858606
• Email: nohahamzawy4[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: November 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• CML, Chronic Phase
• Leukemia, Myeloid, Chronic-Phase

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of weight in kg and height in meter will be combined to measure BMI in (kg/m2)	Base line