CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

Royal Marsden NHS Foundation Trust36 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

CNS Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Royal Marsden NHS Foundation Trust, Downs Road

Sutton, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 5 Years

Contrast clearance analysis

To assess the results of contrast clearance analysis

Time frame: 5 Years

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

GI and Lymphoma Unit

CONTACT

02086426011 GI.Trials@rmh.nhs.uk

Data from ClinicalTrials.gov

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