Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma

Lymphoma Clinical Trial

Official title:

Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464823
• Other study ID #: 2022-0396
• Secondary ID: NCI-2022-05783
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: May 12, 2027

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jason Westin, MD
• Phone: (713) 792-3750
• Email: jwestin[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 12, 2027
• Est. primary completion date: May 12, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• Molecular Functional Portrait
Participants will be asked to allow previously-collected tumor tissue to be used for the MF Portrait test

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   M D Anderson Cancer Center