NCT04244331

Brief Summary

This is a prospective, multicenter study, without any therapeutic intervention that will consist of the analysis of the results of the determination of the COO of all the patients diagnosed with LDCGB in the Spanish hospitals of GELTAMO that adhere to the project. The determination of the COO will be carried out prospectively at the Genomic Unit of the Hospital Clínic de Barcelona (IDIBAPS), where the histological samples of the patients will be sent for this purpose. The main study variable will be the description of the COO (germ-center origin \[GCB\], activated \[ABC\], NOT DETERMINABLE, NOT VALUABLE)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 26, 2024

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 24, 2020

Last Update Submit

February 23, 2024

Conditions

CCO

Outcome Measures

Primary Outcomes (1)

  • Develop Patform

    The objective of the study is to develop a platform for the determination of the COO at a national level by means of NanoString in patients diagnosed with LDCGB and to analyze the distribution of this COO.

    2 years

Secondary Outcomes (2)

  • Integration CCO

    2 years

  • Determination CCO

    15 days

Interventions

CCODIAGNOSTIC_TEST

Determination of COO in tumor biopsies from patients with GBDD using the Lymph2Cx assay using NanoString tectology

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with LDCGB an Age over or equal to 18 years old.

You may qualify if:

  • Patients diagnosed with LDCGB in the Spanish GELTAMO sites, without previous treatment and who decide to join the program.
  • Age over or equal to 18 years old.
  • Having voluntarily given informed consent for the sending and processing of biological samples, as well as for the analysis and reporting of the LDCGB COO results

You may not qualify if:

  • Absence of histological material available to review histology and determine COO
  • Patients with LDCGB from any other low-grade lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GELTAMO

Madrid, 28040, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

TUMMORAL BIOPSIA

Study Design

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

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

May 1, 2018

Primary Completion

May 1, 2019

Study Completion

March 1, 2020

Last Updated

February 26, 2024

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)