The Hong Kong CML Registry
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03625583 |
|
Recruitment Status :
Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Chronic Myeloid Leukemia |
Chronic myeloid leukaemia (CML) is a malignant disorder of the haematopoietic system characterized by the presence of the Philadelphia chromosome arising from t(9;22)(q34;q 11).The annual incidence of CML is reported to be around 1-2 cases per 100,000 population.In Hong Kong, the age-standardised incidence rate of CML has remained static in recent years.
However, as the incidence of CML increases with age and Hong Kong has an ageing population, the crude incidence rate is expected to follow a rising trend. On the other hand, the prognosis of CML patients has improved significantly since the advent of tyrosine kinase inhibitors (TKis) more than two decades ago. With the efficacious TKis, CML has changed from a deadly cancer to a treatable chronic condition. It has been shown that life expectancy of CML patients is approaching that of the general population now.The prevalence of CML is expected to rise considerably in view of the increasing incidence in an ageing population and improved prognosis. The Hong Kong Cancer Registry only provides data on the incidence rates of cancers but it has yet to provide cancer prevalence data. A clinical registry is "an organized system that uses observational study methods to collect uniform data to evaluate specific outcomes". A disease registry specifically designed for CML would provide more accurate and comprehensive data and allow an in-depth study of the epidemiology and characteristics of CML in Hong Kong.
At present,there are three TKis approved for front-line treatment of newly diagnosed chronic-phase CML,viz.,imatinib, nilotinib and dasatinib.lmatinib is a first-generation TKI while nilotinib and dasatinib are second-generation TKis (2G-TKI) . Nilotinib and dasatinib demonstrate better in vitro efficacy and achieve molecular responses faster and deeper than imatinib,but these drugs not been proven superior to imatinib in conventional clinical endpoints including overall survival and progression-free survival.Besides, nilotinib and dasatinib are not without side effects and their long-term safety profiles are unclear. For example, nilotinib is associated with increased cardiovascular risk while dasatinib often leads to pleural effusion and less frequently,pulmonary hypertension.The safety of imatinib has been well established over the past 15 years and its side effects are generally considered tolerable. However, the generic formulation of imatinib has been recently introduced to public hospitals and substituted for branded imatinib in CML patients. There have been reports that patient switching to generic imatinib develop adverse drug reactions not experienced with branded imatinib. Other less commonly used therapeutic agents include bosutinib and ponatinib, which still play an important role in the management of CML. Therefore, it is important to determine the "real-world" clinical effectiveness of various drugs, and monitor their side effects and long-term toxicities in a population-based approach.
As physicians in Hong Kong are facing a growing patient population on long-term TKI,the demand on health care services and financial burden of drug costs will escalate accordingly. lt is pivotal for the investigators to understand the disease and patients in the locality better by systematic data collection, in order to improve quality of care, allow service planning and facilitate medical research and advances .
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | A Multi-centre Study of Epidemiology, Characteristics, Treatment and Outcome of Chronic Myeloid Leukaemia in Adults in Hong Kong |
| Actual Study Start Date : | April 1, 2018 |
| Estimated Primary Completion Date : | March 31, 2023 |
| Estimated Study Completion Date : | September 30, 2023 |
| Group/Cohort |
|---|
|
chronic myeloid leukaemia
chronic myeloid leukaemia diagnosed from 2007 - 2017
|
- Demographics [ Time Frame: January 2007 to December 2017 ]percentage of ethnic distribution
- Age [ Time Frame: January 2007 to December 2017 ]percentage of age distribution
- Etiology [ Time Frame: January 2007 to December 2017 ]percentage of etiology
- Clinical features [ Time Frame: January 2007 to December 2017 ]percentage of clinical features
- Sex [ Time Frame: January 2007 to December 2017 ]ratio of male to female patient
- number of CML patients in Hong Kong [ Time Frame: up to 10 years ]Estimated prevalence of CML in Hong Kong
- number of newly diagnosis CML patient each year [ Time Frame: up to 10 years ]Estimated incidence of CML in Hong Kong
- Current treatment pattern of CML [ Time Frame: up to 10 years ]Current treatment pattern of CML
- record AE of each treatment [ Time Frame: up to 10 years ]Safety data ofTKI
- disease free and survival free [ Time Frame: up to 10 years ]Treatment outcome of CML patients
- disease free and survival free data in advanced phases (accelerated and blast phases) [ Time Frame: up to 10 years ]Outcome of patients in advanced phases (accelerated and blast phases)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
1) Patients less than 18years of age
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625583
| Contact: Dr Carol Cheung, MBBS | 852-22553456 | drcarolcheung@gmail.com | |
| Contact: Crosby Lu, MMedSc | 852-22551654 | khlu@hku.hk |
| Hong Kong | |
| The University of Hong Kong | Recruiting |
| Hong Kong, Hong Kong, 0000 | |
| Contact: Dr Carol Cheung, MBBS 852-22553456 drcarolcheung@gmail.com | |
| Principal Investigator: | Dr Carol Cheung, MBBS | Queen Mary Hospital, Hong Kong |
| Responsible Party: | Professor Yok-lam Kwong, Chair Professor, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT03625583 |
| Other Study ID Numbers: |
QMH-CML-003 |
| First Posted: | August 10, 2018 Key Record Dates |
| Last Update Posted: | August 10, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |