CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CNS Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Imaging and Translational Tissue Study in CNS Lymphoma to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers
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.
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.
Primary outcome measures
- Plasma ctDNA detection [Time frame: 5 Years]
- Contrast clearance analysis [Time frame: 5 Years]
Secondary outcome measures (5)
- Plasma ctDNA detection from end of treatment [Time frame: 5 Years]
- Plasma ctDNA detection rate at baseline [Time frame: 5 Years]
- Plasma ctDNA detection at end of treatment [Time frame: 5 Years]
- Plasma ctDNA detection rate at disease progression [Time frame: 5 Years]
- Radiological data provided by CCA [Time frame: 5 Years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- The Royal Marsden NHS Foundation Trust, Downs Road — Sutton
Identifiers
NCT: NCT05828628 · 5674