NCT03625583

Brief Summary

Chronic myeloid leukaemia (CML) is a malignant disorder of the haematopoietic system. It is characterized by the chromosomal translocation between chromosomes 9 and 22, resulting in the formation of the Philadelphia chromosome which contains the BCRABL1 fusion gene. The projected prevalence of CML is rising steadily, due to the significantly improved survival of CML patients and that the incidence rate increases with age. The efficacious yet costly tyrosine kinase inhibitors pose a significant financial burden to both patients and the health care system, while they carry their own side effects and long-term risks. This study aims to set up a local disease registry of CML to improve the knowledge concerning this disease, including epidemiology,characteristics and treatment outcome of CML in Hong Kong,as well as long-term safety and toxicities of therapeutic agents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

5 years

First QC Date

July 25, 2018

Last Update Submit

August 9, 2018

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (5)

  • Demographics

    percentage of ethnic distribution

    January 2007 to December 2017

  • Age

    percentage of age distribution

    January 2007 to December 2017

  • Etiology

    percentage of etiology

    January 2007 to December 2017

  • Clinical features

    percentage of clinical features

    January 2007 to December 2017

  • Sex

    ratio of male to female patient

    January 2007 to December 2017

Secondary Outcomes (6)

  • number of CML patients in Hong Kong

    up to 10 years

  • number of newly diagnosis CML patient each year

    up to 10 years

  • Current treatment pattern of CML

    up to 10 years

  • record AE of each treatment

    up to 10 years

  • disease free and survival free

    up to 10 years

  • +1 more secondary outcomes

Study Arms (1)

chronic myeloid leukaemia

chronic myeloid leukaemia diagnosed from 2007 - 2017

Eligibility Criteria

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

Descriptive statistics will be used to analyse the characteristics of the CML cohort. Categorical data will be presented with frequency, percentage and 95% confidence interval. Quantitative variables will be presented with median and range, mean and standard deviation when relevant. Survival data will be analysed by the Kaplan-Meier method and competing risks methods. A P value of less than 0.05 will be considered statistically significant. All analyses will be performed using SPSS version 24 and Rsoftware version3.3.2.

You may qualify if:

  • Patients aged 18 years or above
  • Diagnosed with Philadelphia chromosome positive and/or BCR-ABLl positive chronic myeloid leukaemia in all phases
  • Managed in any of the participating centres in the period of 2007 to 2017

You may not qualify if:

  • \) Patients less than 18years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

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 Officials

  • Dr Carol Cheung, MBBS

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Carol Cheung, MBBS

CONTACT

852-22553456drcarolcheung@gmail.com

Crosby Lu, MMedSc

CONTACT

852-22551654khlu@hku.hk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 10, 2018

Study Start

April 1, 2018

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

HK(1)