CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

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CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05828628
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Royal Marsden NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ian Chau
Principal Investigator Affiliation	Royal Marsden NHS Foundation Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	CNS Lymphoma

Additional Details

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.

Arms & Interventions

Arms

: Patients with a new diagnosis of primary or secondary CNS lymphoma

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.