A Study for PRO of CML in Real Word

CML (Chronic Myelogenous Leukemia) Clinical Trial

— Case-Only  

Official title:

Validation Value of the Questionnaire to Assess Health-related Quality of Life in Patients With CML

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092048
• Other study ID #: CML0922
• Status: Recruiting
• Start date: September 22, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: na xu, doctor
• Phone: 02062787883
• Email: 292347668[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Successful outcomes in CML require both prolonged adherence to oral TKI therapy by patients and careful monitoring of treatment responses by their physicians. Patient Reported Outcomes(PRO) assessment is important to facilitate decisions in the current treatment landscape of CML.

Description:

1. Above 18 years of age.

2. Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).

3. Written informed consent.

4. Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 1, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Related Conditions & MeSH terms

• CML (Chronic Myelogenous Leukemia)
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Other:
• questionnaire
PHQ-9 and GAD-7 questionnaire

Locations

Country	Name	City	State
China	Department of Hematology, Nanfang Hospital, Southern Medical University,	Guanzhou

Sponsors (1)

Lead Sponsor	Collaborator
xuna

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia	Health-related quality of life (HRQOL) assessment in the current treatment landscape of chronic myeloid leukemia	1 year