Case-Only: A Study for PRO of CML in Real Word

Sponsor

xuna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05092048

Collaborator

(none)

10,000

Enrollment

Location

12.3

Anticipated Duration (Months)

813.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
CML (Chronic Myelogenous Leukemia)	Other: questionnaire

Detailed Description

Above 18 years of age.
Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
Written informed consent.
Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 22, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
CML patient ≥18 years old CML patiente	Other: questionnaire PHQ-9 and GAD-7 questionnaire

Arm

Intervention/Treatment

CML patient

≥18 years old CML patiente

Other: questionnaire

PHQ-9 and GAD-7 questionnaire

Outcome Measures

Primary Outcome Measures

Assess health-related Quality of Life and Symptom Burden in patients with chronic myeloid leukemia [1 year]
Health-related quality of life (HRQOL) assessment in the current treatment landscape of chronic myeloid leukemia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology, Nanfang Hospital, Southern Medical University,	Guanzhou		China

Sponsors and Collaborators

xuna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

xuna, professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT05092048

Other Study ID Numbers:

CML0922

First Posted:

Oct 25, 2021

Last Update Posted:

Oct 25, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Additional relevant MeSH terms:

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Results

No Results Posted as of Oct 25, 2021