CNS LymphomaCLIMBNCT05828628
CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study
An observational study of CNS Lymphoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lymphoma
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Sep 2023to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed primary CNS lymphoma
Who may be able to join
- 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.
Who cannot join
- Involvement of lymphoma outside of the CNS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust, Downs Road
Sutton, SM2 5PT
GI and Lymphoma Unit, 020 8642 6011, GI.Trials@rmh.nhs.uk
About this study
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
A prospective imaging and translational tissue study in CNS lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.
Read the 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.
- Conditions
- CNS Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a new diagnosis of primary or secondary CNS lymphoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Years
Contrast clearance analysis
To assess the results of contrast clearance analysis
Measured: 5 Years
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start18 Sep 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Chau, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828628
- Sponsor's protocol ID
- 5674
- Acronym
- CLIMB
- Status last verified
- Nov 2024
- First submitted
- 12 Apr 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05828628
- Acronym / sponsor ID
- CLIMB / 5674
- Conditions
- CNS Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a new diagnosis of primary or secondary CNS lymphoma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed primary CNS lymphoma
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Involvement of lymphoma outside of the CNS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma ctDNA detection
Time frame: 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
Time frame: 5 Years
To assess the results of contrast clearance analysis
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Chau principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Lymphoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GI and Lymphoma Unit (02086426011, GI.Trials@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma ctDNA detection (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.