The Molecular Screening and Therapeutics in Leukaemia and Lymphoma Study in participants with haematological malignancies
Evaluate the feasibility and benefits of the Molecular Screening and Therapeutics in Leukaemia and Lymphoma Study, in participants with haematological malignancies
QIMRBerghofer Medical Research Institute
300 participants
Apr 2, 2025
Observational
Conditions
Summary
This study aims to evaluate the feasibility and benefits of molecular screening in participants with haematological malignancies. Who is it for? You may be eligible for this study if you are: - aged 18 years and older - have pathologically confirmed blood cancer at diagnosis or relapsed/refractory disease - have sufficient and accessible tissue for molecular screening - ECOG performance status 0, 1 or 2. Study details If a patient is suitable for the MoST-LLy study, their blood cancer is tested for genetic biomarkers that may guide future treatment/s. This process is called molecular screening or genetic panel testing. After a patient’s blood cancer is tested, a report is sent to the referring haematologist with information on (i) Any genetic biomarkers that were identified in the blood cancer and (ii) The types of treatment/s or clinical trials/s that may be suitable (if any are found). The intervention and results of the screening will be assessed for biomarker identification, treatment recommendations, patient and treatment metrics and clinical outcomes. It is hoped that this research project will contribute to a better understanding of blood cancers and blood cancer genomics that may help people with blood cancer in the future. The results will aim to show genetic screening is important to expedite translation of discovery into treatment options and ultimately better outcomes for blood cancer patients.
Eligibility
Inclusion Criteria5
- Participants, aged 18 years and older, with pathologically confirmed blood cancer at initial diagnosis or relapse/refractory disease.
- Sufficient and accessible tissue for molecular screening.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Willing and potentially able to comply with study requirements.
- Signed, written informed consent to participation in the molecular screening.
Exclusion Criteria2
- Comorbidities or conditions which may contraindicate participation, compromise assessment of key outcomes or limit ability to comply with protocol.
- Patient is eligible for Medicare Benefits scheme (MBS) funded Next Generation Sequencing (NGS), except where there is a clinical rationale to provide a larger sequencing panel or repeat sequencing.
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Interventions
This study will evaluate the feasibility and benefits of a molecular screening platform in participants with haematological malignancies (18 years or over). A national molecular tumour board will send a report to the referring haematologist with information on (i) Any genetic biomarkers that were identified in the blood cancer and (ii) The types of treatment that may be suitable (if any are found). Eligible patients are invited to consent through the completion of a participant information and consent form (PICF). Participants consent to: - a sample of their blood cancer sent for molecular screening. - collection of medical and treatment history - a short questionnaire (6 questions) to be completed after consent and at 6, 12 & 24months - a research blood sample collected (can be done locally) Consent, questionnaires and collection of blood sample may take up to 2 hours. The national Molecular Tumour Board (MTB) of Haematologists, Genetics specialists and invited referring doctors review the results of the molecular screening via video conferencing on a regular basis (weekly/fortnightly as needed). Reports to referring haematologist are aimed to be sent between 6-8 weeks post consent.
Locations(1)
View Full Details on ANZCTR
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ACTRN12625000160437