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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06121765
Other study ID # Metabolic alteration in CML
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT06423911 - A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML Phase 3
Recruiting NCT03459534 - A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs Phase 3
Completed NCT03885830 - Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
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Not yet recruiting NCT05367765 - A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase Phase 4
Recruiting NCT05367700 - A Study of HS-10382 in Patients With Chronic Myeloid Leukemia. Phase 1