CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

CNS Lymphoma Clinical Trial

— CLIMB  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05828628
• Other study ID #: 5674
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: June 2031

Study information

• Verified date: April 2023
• Source: Royal Marsden NHS Foundation Trust
• Contact: Rachel Powell
• Phone: 0203 186 5176
• Email: rachel.powell[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 2031
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CNS Lymphoma
• Lymphoma

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Contrast clearance analysis	To assess the results of contrast clearance analysis	5 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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