Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Primary Objective:
• To determine the feasibility and turnaround of clinical WES and transcriptome sequencing
Secondary Objectives:
- To determine the frequency of actionable DNA and RNA alterations
- To determine the concordance of DNA and RNA alterations
- To determine the frequency of molecularly matched therapy
- To determine the feasibility of identifying mechanism(s) of acquired resistance with genomic profiling
- To determine the feasibility of molecularly matched therapy to acquired resistance alterations
Exploratory Objectives:
- To determine the feasibility of prioritizing targets with precision analytics
- To determine clinical outcomes in patients receiving molecularly matched therapy
- To determine the role of additional emerging diagnostic technologies
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jason Westin, MD
- Phone Number: (713) 792-3750
- Email: jwestin@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Patient Eligibility:
Inclusion Criteria:
- Male/female patients who are at least 18 years of age on the day of informed consent signing.
- Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
- Provision of written informed consent for the study.
Exclusion Criteria:
1. None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Molecular Testing
Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.
|
Participants will be asked to allow previously-collected tumor tissue to be used for the MF Portrait test
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of participants who have genomic test results available in <=7 days
Time Frame: through study completion an average of 1 year
|
through study completion an average of 1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jason Westin, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2022-0396
- NCI-2022-05783 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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