CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study
- Conditions
- CNS Lymphoma
- Registration Number
- NCT05828628
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- Involvement of lymphoma outside of the CNS
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma ctDNA detection 5 Years 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.
Contrast clearance analysis 5 Years To assess the results of contrast clearance analysis
- Secondary Outcome Measures
Name Time Method Plasma ctDNA detection rate at disease progression 5 Years To assess plasma ctDNA detection rate at disease progression using the (i) tumour agnostic and (ii) tumour informed approach
Radiological data provided by CCA 5 Years To evaluate whether additional radiological data provided by CCA is useful for prognostication and is associated with disease progression and survival
Plasma ctDNA detection rate at baseline 5 Years To assess plasma ctDNA detection rate at baseline using the (i) tumour agnostic and (ii) tumour informed approach
Plasma ctDNA detection at end of treatment 5 Years 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
Plasma ctDNA detection from end of treatment 5 Years 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
Trial Locations
- Locations (1)
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom