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

NCT ID: NCT06121765

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-11-30

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.

Conditions

CML, Chronic Phase

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Tyrosine kinase inhibitor

Follow up base metabolic index,lipid profile, HbA1c, thyroid function in CML patients treated with TKI

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Noha Rabea Abdelrahman Soltan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Noha Rabea, Resident doctor

Role: CONTACT

nohahamzawy4@gmail.com

01126858606

Mohamed Ramdan, Professor

Role: CONTACT

dr.muhamadramadan@yahoo.com

Other Identifiers

Metabolic alteration in CML

Identifier Type: -

Identifier Source: org_study_id