Clinical and Genomic Registry of MDS in Asia

NCT03169296 | Unknown DMC

• 1 other identifier: AMWG001
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

Myelodysplastic syndrome (MDS) is a group of clonal haematopoietic stem cell disorders characterized by ineffective haematopoiesis leading to cytopenia, with a significant risk of progression to acute myeloid leukaemia (AML). Progression to AML and resistance to hypomethylating agents (HMA) are important unmet clinical needs. The pathophysiology of MDS and its progression to AML involve cytogenetic, genetic and epigenetic aberrations, and hence better understanding of the molecular landscape of MDS has important clinical implications. Also, future treatment strategies for MDS may involve exploitation of genetic information in designing more effective therapy encompassing single agents or combinatorial approaches. The proposed cohort study aims to establish a registry of clinical and genomic registry of MDS and secondary AML in Asian patients, which allows the establishment of the mutational profile of patients and prognostic model for survival, as well as exploration of treatment strategies and prediction for treatment response.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic syndrome; Mutations; Next-generation sequencing

Outcome Measures

Primary Outcomes (3)

• Time to progression to secondary AML

  60 months

• Overall survival

  60 months

• Progression-free survival

  60 months

Secondary Outcomes (2)

• Time to first response to hypomethylating agent treatment

  60 months

• Best overall response to hypomethylating agent treatment

  60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of MDS recruited is stated in the eligibility criteria

You may qualify if:

• Subject is an adult at the time of diagnosis of MDS. An adult is a person who has attained the legally defined age in accordance with local law.
• Both biological parents and all four biological grandparents of the subject are the original people of the Far East, Southeast Asia, or the Indian subcontinent.
• Subject was diagnosed with one of the following disorders according to the World Health Organization (WHO) classification criteria 2016:
• Myelodysplastic syndrome (MDS)
• Chronic myelomonocytic leukaemia (CMML)
• MDS/ Myeloproliferative neoplasm (MPN) with ring sideroblasts and thrombocytosis (MPN-RS-T)
• MDS/MPN unclassifiable
• In prospective and partial prospective/retrospective case, subject has provided a signed written informed consent of this study. In retrospective case, subject has previously provided a signed written informed consent on:
• voluntary provision of his/her data, and
• voluntary provision of archived/remaining specimens for genetic analysis, and
• authorizing storage and usage of archived/remaining specimens for any further analysis

You may not qualify if:

• Subject was diagnosed with acute myeloid leukaemia under the WHO classification criteria 2016
• Subject was diagnosed with myeloproliferative neoplasms under the WHO classification criteria 2016

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine, the University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Harinder Singh Harry Gill, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harinder Singh Harry Gill, MD

CONTACT

+ 852 22554251; gillhsh@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: May 8, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)