Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
Primary Purpose
Lymphoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molecular Functional Portrait
Sponsored by
About this trial
This is an interventional other trial for Lymphoma
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Molecular Testing
Arm Description
Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.
Outcomes
Primary Outcome Measures
Percentage of participants who have genomic test results available in <=7 days
Secondary Outcome Measures
Full Information
NCT ID
NCT05464823
First Posted
July 12, 2022
Last Updated
August 29, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05464823
Brief Title
Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
Official Title
Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
May 12, 2027 (Anticipated)
Study Completion Date
May 12, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To learn more about the usefulness of molecular testing with the Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Molecular Testing
Arm Type
Other
Arm Description
Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.
Intervention Type
Other
Intervention Name(s)
Molecular Functional Portrait
Intervention Description
Participants will be asked to allow previously-collected tumor tissue to be used for the MF Portrait test
Primary Outcome Measure Information:
Title
Percentage of participants who have genomic test results available in <=7 days
Time Frame
through study completion an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Westin, MD
Phone
(713) 792-3750
Email
jwestin@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Westin, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Westin, MD
Phone
713-792-3750
Email
jwestin@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jason Westin, MD
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
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