Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05464823
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 58.2
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Other: Molecular Functional Portrait	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
• Actual Study Start Date: Jul 7, 2022
• Anticipated Primary Completion Date: May 12, 2027
• Anticipated Study Completion Date: May 12, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Molecular Testing Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.	Other: Molecular Functional Portrait; Participants will be asked to allow previously-collected tumor tissue to be used for the MF Portrait test

Outcome Measures

Primary Outcome Measures

1. Percentage of participants who have genomic test results available in <=7 days [through study completion an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Patient Eligibility:

Inclusion Criteria:

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.

2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.

3. Provision of written informed consent for the study.

Exclusion Criteria:

1. None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Jason Westin, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05464823
• Other Study ID Numbers: 2022-0396; NCI-2022-05783
• First Posted: Jul 19, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Jul 19, 2022