NCT06042660

Brief Summary

The aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed CML patients in a real-world setting. Hematologists from ten Polish hematological tertiary care centers were asked to analyze medical records for all consecutive CML patients diagnosed with chronic phase CML between January 1st 2005 and December 31st 2014.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
527

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 11, 2023

Last Update Submit

September 16, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • the prevalence of comorbid conditions in newly diagnosed CML patients

    data collected through an on-line questionnaire, descriptive data

    February - July 2016

  • the number of concomitant medications in newly diagnosed CML patients

    data collected through an on-line questionnaire, descriptive data

    February - July 2016

Study Arms (1)

newly diagnosed CML patients

Other: the prevalence of comorbid conditions

Interventions

analysis of history of comorbidities at the time of CML diagnosis

newly diagnosed CML patients

Eligibility Criteria

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

Adult patients with diagnosis of chronic phase CML diagnosed between January 1st and December 31st 2014, treated with TKI (imatinib, dasatinib, nilotynib)

You may qualify if:

  • \) age ≥ 18 years; 2) diagnosis of chronic phase CML between January 1st 2005 and December 31st 2014.

You may not qualify if:

  • primary diagnosis of CML in accelerated or blastic phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gora-Tybor J, Sacha T, Waclaw J, Niesiobedzka-Krezel J, Grzybowska-Izydorczyk O, Medras E, Deren-Wagemann I, Patkowska E, Seferynska I, Lewandowski K, Wache A, Blajer-Olszewska B, Watek M, Kotwica-Mojzych K, Wasilewska E, Warzocha K, Jamroziak K. Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis: A Retrospective Analysis of 527 Patients From the Polish Adult Leukemia Group Registry. Clin Lymphoma Myeloma Leuk. 2018 Jul;18(7):e283-e285. doi: 10.1016/j.clml.2018.05.001. Epub 2018 May 9. No abstract available.

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager of Polish Adult Leukemia Group

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

September 18, 2023

Record last verified: 2023-09