Feasibility of Combined Genomics/Transcriptomics for Pati... | NCT05464823

Studies
Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma

NCT05464823

Sponsor

M.D. Anderson Cancer Center

Status

Active, not recruiting

Last Update Posted

Mar 4, 2026Actual

Enrollment

111Actual

Phase

Not Applicable

Conditions

Lymphoma

Interventions

Molecular Functional Portrait

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2022-05783	Other Identifier	NCI-CTRP Clinical Trials Reporting Registry

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2022Actual

Primary Completion Date

May 12, 2027Estimated

Completion Date

May 12, 2027Estimated

First Submitted Date

Jul 12, 2022

First Submission Date that Met QC Criteria

Jul 14, 2022

First Posted Date

Jul 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Molecular Testing	Other	Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.	Other: Molecular Functional Portrait

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Molecular Functional Portrait	Other	Participants will be asked to allow previously-collected tumor tissue to be used for the MF Portrait test	Molecular Testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of participants who have genomic test results available in <=7 days		through study completion an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Westin, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided