Stratified Medicine Paediatrics (StratMedPaeds) - a study looking at genetic changes in children’s cancer

Not Applicable

Active, not recruiting

• Conditions: Solid tumours (including lymphomas) or leukaemia; Cancer

• Registration Number: ISRCTN21731605
• Lead Sponsor: Institute of Cancer Research, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-28
• Last Update Posted: 22 January 2024
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 550

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

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified