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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06121765
Collaborator
(none)
45
25

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Tyrosine kinase inhibitor

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2025
Anticipated Study Completion Date :
Nov 30, 2025

Outcome Measures

Primary Outcome Measures

  1. 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 [Base line]

    Evaluation of weight in kg and height in meter will be combined to measure BMI in (kg/m2)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noha Rabea Abdelrahman Soltan, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06121765
Other Study ID Numbers:
  • Metabolic alteration in CML
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2023