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NCT Number: NCT05828628

CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

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

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Key information

Conditions

CNS Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust, Downs Road

Sutton, SM2 5PT, United Kingdom

Location status: Recruiting

Location contact

GI and Lymphoma Unit

CONTACT

[email protected]

020 8642 6011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Contrast clearance analysis

    Time frame: 5 Years

    To assess the results of contrast clearance analysis

Secondary outcomes

  1. Plasma ctDNA detection from end of treatment

    Time frame: 5 Years

    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

  2. Plasma ctDNA detection rate at baseline

    Time frame: 5 Years

    To assess plasma ctDNA detection rate at baseline using the (i) tumour agnostic and (ii) tumour informed approach

  3. Plasma ctDNA detection at end of treatment

    Time frame: 5 Years

    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

  4. Plasma ctDNA detection rate at disease progression

    Time frame: 5 Years

    To assess plasma ctDNA detection rate at disease progression using the (i) tumour agnostic and (ii) tumour informed approach

  5. Radiological data provided by CCA

    Time frame: 5 Years

    To evaluate whether additional radiological data provided by CCA is useful for prognostication and is associated with disease progression and survival

Study contacts

Contact information is provided by the study sponsor or research team.

GI and Lymphoma Unit

CONTACT

[email protected]

02086426011

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: CLIMB

Important dates

Study start
2023
Primary completion
2028
Study completion
2031
First posted
Apr 25, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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