CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

NCT05828628 | Recruiting

• 1 other identifier: 5674
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Plasma ctDNA detection from end of treatment

  5 Years

• Plasma ctDNA detection rate at baseline

  5 Years

• Plasma ctDNA detection at end of treatment

  5 Years

• Plasma ctDNA detection rate at disease progression

  5 Years

• Radiological data provided by CCA

  5 Years

Study Arms (1)

Patients with a new diagnosis of primary or secondary CNS lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed primary CNS lymphoma

You may qualify if:

• 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.

You may not qualify if:

• \- Involvement of lymphoma outside of the CNS

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust, Downs Road

Sutton, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine FFPE Tissue CSF

Study Officials

• Ian Chau

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GI and Lymphoma Unit

CONTACT

02086426011; GI.Trials@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2031
• Last Updated: June 11, 2025

Record last verified: 2024-11

Locations

GB (1)