CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study (CLIMB)

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.

Study Overview

• Status: Recruiting
• Conditions: CNS Lymphoma

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 Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: GI and Lymphoma Unit; Phone Number: 02086426011; Email: GI.Trials@rmh.nhs.uk

Study Locations

• United Kingdom
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • The Royal Marsden NHS Foundation Trust, Downs Road
    • Contact: GI and Lymphoma Unit; Phone Number: 020 8642 6011; Email: GI.Trials@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed primary CNS lymphoma

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with a new diagnosis of primary or secondary CNS lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 Years
Contrast clearance analysis	To assess the results of contrast clearance analysis	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	5 Years

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Ian Chau, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 5674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No