Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
COGET-B
Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
1 other identifier
observational
200
1 country
1
Brief Summary
DLBCL has the highest frequency out of all lymphoid malignancies. With the recent development of antitumor agents targeting intracellular/extracellular cell signaling pathways, patients have access to various treatment options after relapse. Therefore, for the purpose of developing effective treatment strategies, large-scale genomic data accumulation is necessary to understand the mechanism of relapse and refractory state of DLBCL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedStudy Start
First participant enrolled
September 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedMarch 18, 2020
March 1, 2020
2.4 years
May 17, 2019
March 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Next generation sequencing with tumor tissue
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
2-year follow-up from the end of the enrollment
Next generation sequencing with blood
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
2-year follow-up from the end of the enrollment
Secondary Outcomes (2)
Data which included salvage chemotherapy.
2-year follow-up from the end of the enrollment
Data which included survival outcome.
2-year follow-up from the end of the enrollment
Eligibility Criteria
Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.
You may qualify if:
- Histopathologically confirmed DLBCL
- DLBCL who relapsed or were refractory to first-line treatment with rituximab-based immunotherapy
- Available for genomic analysis of tissues both at diagnosis (paraffin-embedded and stored) and at relapse (paraffin-embedded)
- Aged ≥18 years
- Written informed consent for participation in the prospective cohort study
- Written informed consent to peripheral blood collection and genetic testing of human tissues
You may not qualify if:
- No lymphoid malignancy, e.g. myeloid leukemia
- Any of the following lymphoid malignancies:
- Plasma cell dyscrasia, amyloidosis
- Hodgkin lymphoma
- Subtypes of B cell non-Hodgkin lymphoma, other than DLBCL
- T or NK(Natural Killer) cell non-Hodgkin lymphoma
- Other diseases in the WHO(World Health Organization) classification of lymphoid malignancies
- Experienced a relapse before
- Insufficient or no tissue sample at diagnosis for genomic analysis
- Can not understand or provide written informed consent
- Who do not provide written informed consent to blood collection and genetic testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
Biospecimen
1. Blood sample : SST(Serum Separation Tube) 3ml, EDTA (Ethylenediaminetetraacetic Acid) 3ml 2. Tissue : unstained slides ((at least) 5 slides with a thickness of 5 microns)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2019
First Posted
June 6, 2019
Study Start
September 24, 2019
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
March 18, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
* Data management of this clinical trial should be done in accordance with the ICH(International Conference on Harmonization)-GCP(Good Clinical Practice) and KGCP (Korean Good Clinical Practice)guidelines. To ensure the anonymity of subjects, each subject will be identified and managed by a randomly assigned subject number, instead of his/her name, in all documents so that persons not involved in the study could not identify subjects from their personal data. * Subjects participating in this clinical trial may have to provide some of their personal information, but such information will not be directly used or necessary in the study but will be used only for the purpose of connecting clinical data obtained for the clinical trial. Collected information will be used until the clinical trial report is complete.