Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cell-free DNA.
- Who it may be relevant to
- Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.
Detailed description
Primary Objective:
• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.
Secondary Objectives:
* To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations * Levels of cfDNA and its association with both EFS and OS in patients receiving therapy
Interventions
- Diagnostic test cell-free DNA
Given by IV (vein)
Primary outcome measures
- Overall Survival (OS) [Time frame: through study completion; an average 1 year]
Eligibility criteria
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.
- Pregnant women not included
- Cognitively impaired adults are not included.
Exclusion criteria
None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- MD Anderson Cancer Center — Houston
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT05676450 · 2022-0603 · NCI-2022-10562