NCT07200882

Brief Summary

Evaluation of the impact of various TKI on thyroid function in patients diagnosed with cml

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Nov 2025

Typical duration for all trials

Status
not yet recruiting

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

Study Progress25%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 23, 2025

Last Update Submit

September 23, 2025

Conditions

Leukaemia (Chronic)

Outcome Measures

Primary Outcomes (1)

  • the impact of TKIs on thyroid in patients with Cml

    To evaluate the impact of TKIs on thyroid in patients with Cml by measuring changes in thyroid hormone levels ( TSH Free T4 Free T3) over time and determining the prevalence of thyroid disorder (hyperthyroidism and hypothyroidism )among tki treated patients

    1 year

Eligibility Criteria

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

Philadelphia chromosome positive. CML patients

You may qualify if:

  • Patients age from 18 to 65 year
  • Newly diagnosed CML patients with Philadelphia chromosome positive based on peripheral blood findings and molecular analysis for the BCR-ABL mutation initiating ttt with a TKI (Philadelphia chromosome positive. CML patients )

You may not qualify if:

  • any history of using drugs interfering with TKI or having effect on thyroid function (Dexamethasone, Phenytoin, Carbamazepine, Rifampin and Phenobarbital)
  • Patients with a history of thyroid disease ( hypo or hyperthyroidism or auto immunity )or are already on treatment for thyroid dysfunction
  • pregnancy and lactation
  • concomitant use of oral contraceptive pills or corticosteroids.
  • Other malignancies requiring concurrent treatment
  • previous ttt with TKI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Hematology and Endocrinology units

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 1, 2025

Record last verified: 2025-09