CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

Study Overview
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Brief Summary
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A prospective imaging and translational tissue study in CNS lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.

Detailed Description
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As a single centre exploratory study, this trial will recruit patients with newly diagnosed primary CNS lymphoma and will look at the molecular aspects of the disease in the tissue collection and imaging response assessments using CCA with respect to progression free survival.

Official Title
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A Prospective Imaging and Translational Tissue Study in CNS Lymphoma to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers

Conditions
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CNS Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects capable of giving informed consent, or if appropriate, if subject's capacity is deemed limited due to CNS involvement, a consultee can provide consent on their behalf. Some patients with PCNSL may be incapable of providing their own consent due to the neurological effects of their disease. In these cases the patient will be classed as an incapacitated adult and a legal representative will be sought in accordance with English or Scottish law as applicable (see 7.2.1) A radiological or histological diagnosis of primary CNS lymphoma. Have not received prior CNS directed therapy. Prior use of steroids is permitted. Participants aged ≥18 years old. Exclusion Criteria: - Involvement of lymphoma outside of the CNS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with a new diagnosis of primary or secondary CNS lymphoma<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma ctDNA detection | To assess if plasma ctDNA detection measured from end of treatment (using the tumour informed approach) can be used an early detection tool for progressive disease. | 5 Years | 
| Contrast clearance analysis | To assess the results of contrast clearance analysis | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma ctDNA detection from end of treatment | To assess if plasma ctDNA detection measured from end of treatment (using the tumour agnostic approach) can be used as an early detection tool for progressive disease | 5 Years | 
| Plasma ctDNA detection rate at baseline | To assess plasma ctDNA detection rate at baseline using the (i) tumour agnostic and (ii) tumour informed approach | 5 Years | 
| Plasma ctDNA detection at end of treatment | To assess whether plasma ctDNA detection at end of treatment can be used an early detection tool for progressive disease and survival using the (i) tumour agnostic and (ii) tumour informed approach | 5 Years | 
| Plasma ctDNA detection rate at disease progression | To assess plasma ctDNA detection rate at disease progression using the (i) tumour agnostic and (ii) tumour informed approach | 5 Years | 
| Radiological data provided by CCA | To evaluate whether additional radiological data provided by CCA is useful for prognostication and is associated with disease progression and survival | 5 Years |