NCT04139252

Brief Summary

Observational prospective study. Patients with DLBCL and HGBCL will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

60 active sites

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

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 17, 2020

Completed
3.2 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

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

October 23, 2019

Last Update Submit

April 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tissue material

    For genomic analysis and clinical outcome data

    24 months

Interventions

No intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who meet the eligibility criteria

You may qualify if:

  • Patients diagnosed with newly diagnosed DLBCL (including HGBCL- NOS and HGBCL-DH) according to WHO classification 2016
  • Ann Arbor stage II-IV
  • Age ≥ 18 years

You may not qualify if:

  • \- Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

Location

NL-Alkmaar-NWZ

Alkmaar, Netherlands

Location

NL-Almelo-ZGTALMELO

Almelo, Netherlands

Location

NL-Almere-FLEVOZIEKENHUIS

Almere Stad, Netherlands

Location

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

Location

NL-Amstelveen-AMSTELLAND

Amstelveen, Netherlands

Location

NL-Amsterdam-AMC

Amsterdam, Netherlands

Location

NL-Amsterdam-OLVG

Amsterdam, Netherlands

Location

NL-Amsterdam-VUMC

Amsterdam, Netherlands

Location

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

Location

NL-Assen-WZA

Assen, Netherlands

Location

NL-Beverwijk-RKZ

Beverwijk, Netherlands

Location

NL-Breda-AMPHIA

Breda, Netherlands

Location

NL-Capelle a/d IJssel-YSL

Capelle aan den IJssel, Netherlands

Location

NL-Delft-RDGG

Delft, Netherlands

Location

NL-Deventer-DZ

Deventer, Netherlands

Location

NL-Dirksland-VANWEELBETHESDA

Dirksland, Netherlands

Location

NL-Doetinchem-SLINGELAND

Doetinchem, Netherlands

Location

NL-Dordrecht-ASZ

Dordrecht, Netherlands

Location

NL-Ede-ZGV

Ede, Netherlands

Location

NL-Eindhoven-CATHARINA

Eindhoven, Netherlands

Location

NL-Eindhoven-MAXIMAMC

Eindhoven, Netherlands

Location

NL-Emmen-SCHEPER

Emmen, Netherlands

Location

NL-Enschede-MST

Enschede, Netherlands

Location

NL-Geldrop-STANNA

Geldrop, Netherlands

Location

NL-Goes-ADRZ

Goes, Netherlands

Location

NL-Gorinchem-BEATRIX

Gorinchem, Netherlands

Location

NL-Gouda-GROENEHART

Gouda, Netherlands

Location

NL-Groningen-UMCG

Groningen, Netherlands

Location

NL-Hardenberg-SAXENBURGH

Hardenberg, Netherlands

Location

NL-Harderwijk-STJANSDALHARDERWIJK

Harderwijk, Netherlands

Location

NL-Heerenveen-TJONGERSCHANS

Heerenveen, Netherlands

Location

NL-Helmond-ELKERLIEK

Helmond, Netherlands

Location

NL-Hoofddorp-SPAARNEGASTHUIS

Hoofddorp, Netherlands

Location

NL-Hoorn-DIJKLANDERHOORN

Hoorn, Netherlands

Location

NL-Leeuwarden-MCL

Leeuwarden, Netherlands

Location

NL-Leiden-LUMC

Leiden, Netherlands

Location

NL-Maastricht-MUMC

Maastricht, Netherlands

Location

NL-Nieuwegein-ANTONIUS

Nieuwegein, Netherlands

Location

NL-Nijmegen-CWZ

Nijmegen, Netherlands

Location

NL-Roermond-LZR

Roermond, Netherlands

Location

NL-Roosendaal-BRAVIS

Roosendaal, Netherlands

Location

NL-Rotterdam-ERASMUSMC

Rotterdam, Netherlands

Location

NL-Rotterdam-IKAZIA

Rotterdam, Netherlands

Location

NL-Rotterdam-MAASSTADZIEKENHUIS

Rotterdam, Netherlands

Location

NL-Rotterdam-SFG

Rotterdam, Netherlands

Location

NL-Sneek-ANTONIUSSNEEK

Sneek, Netherlands

Location

NL-Spijkenisse-SPIJKENISSEMC

Spijkenisse, Netherlands

Location

NL-Terneuzen-ZORGSAAM

Terneuzen, Netherlands

Location

NL-Den Haag-HAGA

The Hague, Netherlands

Location

NL-Den Haag-HMCWESTEINDE

The Hague, Netherlands

Location

NL-Tiel-RIVIERENLAND

Tiel, Netherlands

Location

NL-Tilburg-ETZ

Tilburg, Netherlands

Location

NL-Uden-BERNHOVEN

Uden, Netherlands

Location

NL-Utrecht-DIAKONESSENUTRECHT

Utrecht, Netherlands

Location

NL-Utrecht-UMCUTRECHT

Utrecht, Netherlands

Location

NL-Venlo-VIECURI

Venlo, Netherlands

Location

NL-Winterswijk-SKBWINTERSWIJK

Winterswijk, Netherlands

Location

NL-Zutphen-GELREZUTPHEN

Zutphen, Netherlands

Location

NL-Zwolle-ISALA

Zwolle, Netherlands

Location

Study Officials

  • M.E.D. Chamuleau, MD, PhD

    VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

March 17, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations