Relapsed/refractory solid tumours (including lymphomas) or leukaemia Cancer
Conditions
Interventions
StratMedPaeds2 is a prospective cohort molecular profiling study that will generate highly annotated clinical and molecular data to highlight novel and potentially druggable dependencies enriched at t
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 0-21 years (patients > 21yo where primary cancer is classified as a “paediatric specific malignancy”) 2. Patients with relapsed/refractory paediatric solid & CNS tumours, Leukaemia and Lymphoma. Note: refractory leukaemia will only be eligible where no standard 2nd line treatment is available. Contact the leukaemia lead prior to registration 3. For solid tumours: Patient has a Formalin fixed paraffin embedded (FFPE) tumour (mandatory) and fresh frozen tumour (if available) from a biopsy, resection or other surgical procedure that was taken within 8 weeks prior to study entry (as part of NHS SoC). Fresh frozen tumour tissue is highly encouraged*1. 4. For leukaemia –Viable fresh or frozen Bone Marrow aspirate sample taken at a prior assessment within 8 weeks prior to study entry*2 (taken as part of NHS SoC) For BM and combined relapses where bone marrow is unavailable, a peripheral blood sample can be provided if circulating blasts are confirmed on morphology or flow cytometry. 5. For isolated CNS/Combined relapses where bone marrow is unavailable or BM is uninvolved with leukaemia, a CSF sample should be provided (taken as part of NHS SoC). 6. Written informed consent of patient/parent/guardian *1. 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 the same shipment (see laboratory manual for further details). For CNS tumours only: blood and CSF samples paired with initial SoC tumour tissue samples *2. 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.
Exclusion criteria
Exclusion criteria: Not meeting the participant inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genetic changes in the patient's relapsed/refractory cancer cells will be studied using genetic analysis in both the tumour and blood at the time of relapse and throughout their treatment journey to fulfil the following objectives: 1. The proportion of patients in whom clinically relevant genomic events are detected at the time of relapse 2. The proportion of patients in whom treatment is altered or who have a positive diagnosis as a direct result of either tissue or liquid biopsies. 3. The frequency and spectrum of events detected at the time of relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Genetic changes in the patient's relapsed/refractory cancer cells will be studied using genetic analysis in both the tumour and blood at the time of relapse and throughout their treatment journey to fulfil the following objectives: 1. Proportion of diagnoses that are refined as a result of molecular testing 2. Percentage of cases in which long-read sequencing reports a methylation classifier for diagnosis of CNS tumours and sarcoma 3. The proportion of patients on therapy who develop actionable or novel treatment resistance 4. mutations identified in serial liquid biopsy 5. Association of ctDNA levels by serial liquid biopsy during treatment with clinical and/or radiological Indicators of progression 6. The turnaround time (TAT) from receipt of sample at GOSH to discussion of results at MTB 7. The identification of events which contribute to TAT, beginning from patient consent to final reporting via the MTB | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactAmina Bukhari
Outcome results
None listed