NCT06121765

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 29, 2023

Last Update Submit

November 6, 2023

Conditions

Outcome Measures

Primary Outcomes (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

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

    Base line

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Patient newly diagnosed with CML and received TKI

You may not qualify if:

  • patient previously diagnosed CML and started treatment or in post treatment follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Tyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein Kinase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Noha Rabea, Resident doctor

CONTACT

Mohamed Ramdan, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 8, 2023

Study Start

November 1, 2023

Primary Completion

October 30, 2025

Study Completion

November 30, 2025

Last Updated

November 8, 2023

Record last verified: 2023-11