NCT04112238

Brief Summary

The study is a prospective clinical study which investigates the use of new diagnostic methods to localize aggressive lymphoma involving the central nervous system(CNS). By measuring cell-free tumor DNA and metabolomics in cerebrospinal fluid and blood in patients with systemic Diffuse Large B-cell Lymphoma the investigators aim to improve the diagnostic certainty of an impending relapse of lymphoma in CNS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

September 30, 2019

Last Update Submit

March 21, 2022

Conditions

Diffuse Large B Cell LymphomaCentral Nervous System Metastasis

Outcome Measures

Primary Outcomes (1)

  • CSF tumor cfDNA and metabolite detectability and cytological/flow cytometric confirmation of CNS lymphoma at the time of diagnosis and relapse

    Two years

Secondary Outcomes (10)

  • Progression free survival, PFS (time between inclusion and progression or relapse or beginning of a new treatment)

    Two years

  • Overall survival, OS (time between inclusion and death)

    Two years

  • Comparison of tumor cfDNA and metabolite levels and composition in CSF with levels in plasma at the time of diagnosis and relapse

    Two years

  • For patients with both a pre- and a post-treatment CSF sample: correlation of cfDNA/metabolite levels pre-treatment to post-treatment with OS and risk of relapse.

    Two years

  • Correlation of tumor cfDNA and metabolite levels and composition in CSF and patient survival at the time of diagnosis and relapse

    Two years

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See above

You may qualify if:

  • Verified or suspected primary CNS lymphoma or verified or suspected DLBCL relapsed in the CNS
  • Treatment of the relapse not initiated (except pretreatment with corticosteroids)
  • Age ≥ 18 years
  • Patient must consent to genetic and metabolomic analysis of their cancer
  • Written informed consent

You may not qualify if:

  • Evidence of a CNS mass creating mass-effect or midline shift such that lumbar puncture is contraindicated
  • Other contraindications to lumbar puncture according to local guidelines
  • Other previous or current hematological malignancy
  • Prior treatment for CNS disease (except CNS prophylaxis in first line lymphoma treatment)
  • Known CNS autoimmune or inflammatory disease
  • Known HIV infection
  • Patient is currently receiving treatment for DLBCL
  • Study 1
  • Previously diagnosed histologically documented DLBCL
  • Verified relapsed DLBCL
  • ≥ 1 prior DLBCL treatments
  • Treatment of the relapse not initiated (except pretreatment with corticosteroids)
  • Being able to undergo standard assessment ( eg, Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET), MRI of the neuroaxis and bone marrow biopsy)
  • Tumor biopsy and/or bone-marrow biopsy used for diagnosis available
  • Age ≥ 18 years
  • +34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hopital

Herlev, Capital Region, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Anne Elisabeth Reuben Tolley, MD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Elisabeth Reuben Tolley, MD

CONTACT

+4538686877anne.elisabeth.reuben.tolley@regionh.dk

Lars Møller Pedersen, MD, PhD

CONTACT

+4538686527lars.moeller.pedersen.1.@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

August 29, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

DK(1)