Solid tumours (including lymphomas) or leukaemia Cancer
Conditions
Interventions
Current interventions as of 15/03/2023:
Patients with clinically relapsed/refractory progressive solid tumours (including brain and lymphomas) or leukaemia who undergo a biopsy as part of their stan
Sponsors
Institute of Cancer Research, London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/03/2023: 1. Patients with a relapsed or refractory paediatric tumour (all solid tumours, central nervous system (CNS) tumours and lymphoma) or leukaemia 2. For solid tumours: Formalin fixed paraffin embedded (FFPE) tumour available from a biopsy, resection or other surgical procedure that was taken within 8 weeks of trial entry* 3. For leukaemia: Viable fresh or frozen Bone Marrow aspirate sample taken at a prior assessment within 8 weeks prior to trial entry** 3. Written informed consent of patient/parent/guardian/legal guardian*** * To allow full multi-omic analysis both fresh frozen and Formalin fixed paraffin embedded (FFPE) tumour plus a blood sample for constitutional (germline) and circulating tumour (ct) DNA will need to be available. Original diagnostic slides should be submitted at the same time as block from current relapse/refractory episode either in same shipment. ** Where available, a cerebrospinal fluid (CSF) sample in the event of an isolated or combined CNS relapse should also be provided in addition to the bone marrow aspirate. *** Some adult patients with brain tumours or brain metastases may be incapable of providing their own consent due to the neurological effects of their disease. In such cases, these patients will be classed as an incapacitated adult and a consultee will be sought. _____ Previous inclusion criteria: 1. Patients with a relapsed or refractory paediatric tumour (all solid tumours, central nervous system (CNS) tumours and lymphoma) 2. Formalin fixed paraffin embedded (FFPE) tumour available from a biopsy, resection or other surgical procedure that was taken within 8 weeks of trial entry* 3. Written informed consent of patient/parent/guardian/legal guardian** * To allow full multi-omic analysis both fresh frozen and Formalin fixed paraffin embedded (FFPE) tumour plus a blood sample for constitutional (germline) and circulating tumour (ct) DNA will need to be available. Original diagnostic slides should be submitted at the same time as block from current relapse/refractory episode either in same shipment or via PathXL (see laboratory manual for further details). ** Some adult patients with brain tumours or brain metastases may be incapable of providing their own consent due to the neurological effects of their disease. In such cases, these patients will be classed as an incapacitated adult and a consultee will be sought.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cases referred that receive a Molecular Tumour Board Report within 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes to be achieved within a timescale of up to 3 years: 1. The number and proportion of samples successfully analysed 2. The reasons for analysis failure 3. The proportion of patients with known or unknown somatic molecular alterations 4. The proportion of patients with actionable molecular alterations in tumours 5. The proportion of patients in which any treatment recommendation can be made 6. The proportion of patients in which a treatment recommendation with a molecularly targeted therapy can be made 7. The proportion of patients successfully registered on to clinical trials 8. The proportion of patients successfully registered on to clinical trials of molecularly targeted therapies 9. The proportion of patients who have their diagnosis changed following multi-omic analysis 10. Progression Free Survival (PFS) 11. Any complications of biopsy 12. The proportion of patients with germline events 13. The proportion of patients recommended for clinical genetics service referral 14. Collection of data on individual genomic, epigenomic and transcriptomic characteristics of refractory/relapsed paediatric malignancies (added 15/03/2023) 15. The number and proportion of leukaemia samples successfully analysed on the DRP platform 16. The number and proportion of patients with leukaemia who have a potential therapy identified through the DRP platform Numerical data will be taken from the case report forms from each participating hospital site. Case report forms will be completed using information taken from the patient’s medical record. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed