None listed
Conditions
Brief summary
The primary purpose of this study is to provide long-term patient follow-up, and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients age 18 years or older, with a new diagnosis of Myelodysplastic syndrome (MDS). Study details Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the Myelodysplastic syndrome database using a web portal: • Health at diagnosis • Demographic details • Laboratory and bone marrow biopsy results at diagnosis including cytogenetics and molecular studies if available • Therapy decisions including pharmacological agents, transfusion practice and supportive therapy, and side effects of treatment • Outcomes (overall and progression free survival, duration of response and time to next treatment and quality of life measures – EORTC QLQ-C30, QUALMS) • Long-term outcomes (through linkage with Cancer and Death Registries) Patients are asked to completed both questionnaires 6 monthly up to 3 years either at their hospital appointment or send to them via email. It is hoped that the data collected for this registry will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies for Myelodysplastic syndrome and will assist with monitoring patient access to care, as well as monitoring trends in Myelodysplastic syndrome incidence and survival in Australia.
Interventions
This patient registry is using the registry as a framework to collect data on patient demographics including family history, relevant clinical results, treatment history, participant and survival status.
The data is obtained from participating hospitals accessing the medical records by hospital staff/ authorised staff.
Patients are asked to complete the EORTC QLQ-C30 and QUALMS questionnaire as part of their follow up appointments whilst being at the hospital or can be send out via email, if th
This patient registry is using the registry as a framework to collect data on patient demographics including family history, relevant clinical results, treatment history, participant and survival status. The data is obtained from participating hospitals accessing the medical records by hospital staff/ authorised staff. Patients are asked to complete the EORTC QLQ-C30 and QUALMS questionnaire as part of their follow up appointments whilst being at the hospital or can be send out via email, if that is an option for the patient. This is anticipated to take about 15-20 minutes. The questionnaires occur 6 monthly up to 3 years. Depending on the set up patients can complete the questionnaire via email link at home in their own time and by submitting this information is directly captured in an electronic case report form (CRF). If the patient is at the hospital, the questionnaires will be provided and to be completed after the appointment. A nurse or trained staff will assist to answer questions, if necessary, check for completeness and will collect the questionnaires to enter into the database.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with a new diagnosis of MDS confirmed on bone marrow biopsy. • This will include new diagnosis within 12 months prior to HREC approval at the site. • Or, cause of death listed as MDS within 12 months prior to HREC approval at the site.
Exclusion criteria
Patients who have chosen to ‘opt-out’ of the Registry.
Outcome results
None listed