Trial Summary
What is the purpose of this trial?This trial involves collecting DNA from blood samples of DLBCL patients to monitor their cancer and treatment response. By analyzing this DNA, doctors can identify changes in the cancer and check if any cancer cells remain after treatment.
What data supports the idea that Cell-free DNA Testing for Lymphoma is an effective treatment?The available research shows that Cell-free DNA Testing for Lymphoma is effective because it allows doctors to monitor the disease and adjust treatments in real time. This method is noninvasive, meaning it doesn't require surgery or other intrusive procedures, and it can be done quickly and at a low cost. It helps in detecting changes in the disease, like resistance to standard treatments, and can predict how well a patient is responding to therapy. Compared to traditional methods, this testing provides a simpler and faster way to gather important information about the disease, making it a valuable tool in managing lymphoma.12345
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is cell-free DNA testing a promising treatment for lymphoma?Yes, cell-free DNA testing is a promising treatment for lymphoma. It helps doctors find tumor DNA in the blood without needing a biopsy, track changes in the tumor, and check if the disease is still present after treatment. This makes it easier to diagnose, monitor, and manage lymphoma.12349
What safety data exists for cell-free DNA testing in lymphoma treatment?The research does not specifically address safety data for cell-free DNA (cfDNA) or circulating tumor DNA (ctDNA) testing in lymphoma treatment. However, it highlights that ctDNA testing is minimally invasive, involves peripheral blood testing, and can complement traditional tissue biopsies. The studies emphasize the need for technical standardization and prospective validation in clinical studies to determine its clinical utility. No specific safety concerns are mentioned, suggesting that the focus is on its potential as a diagnostic and monitoring tool rather than direct treatment.46789
Eligibility Criteria
This trial is for adults over 18 with diffuse large B-cell lymphoma (DLBCL) needing treatment. Participants must be able to give written consent and should not be pregnant or cognitively impaired. The study aims to include a diverse group from community centers across Texas.Treatment Details
The trial is exploring the use of cell-free DNA (cfDNA) as a tool to detect genetic changes in DLBCL patients and monitor minimal residual disease after treatment. cfDNA samples are taken from blood drawn through vein puncture before and after therapy.
1Treatment groups
Experimental Treatment
Group I: cell-free DNA (cfDNA) samplesExperimental Treatment1 Intervention
cell-free DNA (cfDNA) samples from DLBCL participants 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.
Blood will be drawn 3 times (by vein)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cancer Therapy and Research Center at The UT Health Science Center at San AntonioSan Antonio, TX
MD Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
References
[Quantitation of Circulating Cell-free DNA in Patients with Lymphoma and Its Clinical Significance]. [2018]To evaluate the value of circulating cell-free DNA (CFDNA) quantification for screening lymphoma, to analyse the relationship of circulating CFDNA with curative effect under standard therapeutic schedule, and to determine whether circulating CFDNA could be applied to monitor and prognosticate lymphoma.
Updates on Circulating Tumor DNA Assessment in Lymphoma. [2019]The use of circulating tumor DNA (ctDNA) for the purposes of diagnosis, prognosis, assessment of treatment response, and monitoring for relapse is a new and developing field in lymphoma. This review aims to summarize many of the most recent advances in ctDNA applications.
The analysis of cell-free DNA concentrations and integrity in serum of initial and treated of lymphoma patients. [2019]To evaluate cell-free DNA (cfDNA) in plasma as a promising biomarker for lymphoma, altered levels of cfDNA and its association with clinical parameters are investigated in patients suffered from lymphomas.
Methods for Measuring ctDNA in Lymphomas. [2019]Plasma cell-free DNA (cfDNA) is an easily accessible source of tumor DNA that allows accurate profiling of lymphoma patients, representing a complementary source of tumor DNA to tissue biopsy for genotyping. Applications of cfDNA analysis in lymphomas include: (1) identification of tumor mutations in a biopsy-free manner; (2) tracking tumor clonal evolution and identification of mutations causing resistance to treatment; and (3) monitoring of residual disease after therapy.
Cell-free DNA and the monitoring of lymphoma treatment. [2020]The technique of cell-free DNA (cfDNA) analysis, also called liquid biopsy, has been developed over the past several years to serve as a minimal residual disease tool, as has already been done with reliability and robustness in acute leukemias. This technique has important theoretical advantages, including the simplicity of acquiring blood samples, which can easily be repeated over time, its noninvasive and quantitative nature, which provides results consistent with the results obtained from tumor genomic DNA, and its speed and low cost. cfDNA analysis, as the leading tool to quantify somatic mutations, is a major technological leap in the noninvasive management of lymphomas. This technology may empower monitoring and treatment adjustment in real time and enable the quick detection of refractory lymphomas and resistance to routine therapies. Here, we summarize the results that have established the clinical relevance of cfDNA in diagnostic and prognostic stratification and the monitoring of lymphoma treatments.
Potential of Circulating Tumor DNA for the Management of Patients With Lymphoma. [2021]The characterization of circulating tumor-derived DNA (ctDNA) has recently emerged in the field of oncology as a powerful method to identify tumor-specific genetic aberrations using peripheral blood testing. Several technical precautions are needed at the pre-analytic stage (given the short half-life of free nucleic acids in plasma), and numerous techniques-with different sensitivities-are available to identify these molecular aberrations, ranging from the detection of single point mutations to extended genetic screening panels. Although a "liquid biopsy" cannot be substituted for the pathological examination of tissue specimens for diagnostic purposes, it can sometimes complement pathology results or serve as a proxy approach for particular lymphoma presentations where biopsies are sometimes difficult to perform. Moreover, ctDNA testing can characterize, at diagnosis or during treatment, mutations that may contribute to the choice of an optimal targeted therapy (such as Bruton tyrosine kinase or EZH2 inhibitors) or detect the emergence of resistance to those therapies. High levels of ctDNA before treatment appear to be correlated with advanced disease stages and prognosis in diffuse large B-cell and follicular lymphomas. Real-time follow-up of ctDNA levels during therapy in several lymphoma subtypes (diffuse large B-cell and Hodgkin lymphomas) has been explored: preliminary studies have demonstrated that this monitoring technique can predict clinical outcomes (end of treatment response and risk of progression after treatment completion) and that this approach may complement the information provided by metabolic imaging assessments. Technical standardization and careful prospective evaluation of the role of ctDNA monitoring in clinical studies represent current important challenges to allowing its application in routine practice.
Circulating tumour DNA in B-cell lymphomas: current state and future prospects. [2021]Circulating tumour DNA (ctDNA) is a highly versatile analyte and an emerging biomarker for detection of tumour-specific sequences in lymphoid malignancies. Since ctDNA is derived from tumour cells throughout the body, it overcomes fundamental limitations of tissue biopsies by capturing the complete molecular profile of tumours, including those from inaccessible anatomic locations. Assays for ctDNA are minimally invasive and serial sampling monitors the effectiveness of therapy and identifies minimal residual disease below the detection limit of standard imaging scans. Dynamic changes in ctDNA levels measure real-time tumour kinetics, and early reductions in ctDNA during treatment correlate with clinical outcomes in multiple B-cell lymphomas. After therapy, ctDNA can effectively discriminate between patients who achieved a complete molecular remission from those with residual treatment-resistant disease. Serial monitoring of ctDNA after therapy can detect early molecular relapse and identify drug-resistant clones that harbour targetable mutations. In order for ctDNA to reach its full potential, the standardization and harmonization of the optimal pre-analytical and analytical techniques for B-cell lymphomas is a critically necessary requirement. Prospective validation of ctDNA within clinical studies is also required to determine its clinical utility as an adjunctive decision-making tool.
Circulating tumor DNA in B-cell lymphoma: technical advances, clinical applications, and perspectives for translational research. [2023]Noninvasive disease monitoring and risk stratification by circulating tumor DNA (ctDNA) profiling has become a potential novel strategy for patient management in B-cell lymphoma. Emerging innovative therapeutic options and an unprecedented growth in our understanding of biological and molecular factors underlying lymphoma heterogeneity have fundamentally increased the need for precision-based tools facilitating personalized and accurate disease profiling and quantification. By capturing the entire mutational landscape of tumors, ctDNA assessment has some decisive advantages over conventional tissue biopsies, which usually target only one single tumor site. Due to its non- or minimal-invasive nature, serial and repeated ctDNA profiling provides a real-time picture of the genetic composition and facilitates quantification of tumor burden any time during the course of the disease. In this review, we present a comprehensive overview of technologies used for ctDNA detection and genotyping in B-cell lymphoma, focusing on pre-analytical and technical requirements, the advantages and limitations of various approaches, and highlight recent advances around improving sensitivity and suppressing technical errors. We broadly review potential applications of ctDNA in clinical practice and for translational research by describing how ctDNA might enhance lymphoma subtype classification, treatment response assessment, outcome prediction, and monitoring of measurable residual disease. We finally discuss how ctDNA could be implemented in prospective clinical trials as a novel surrogate endpoint and be utilized as a decision-making tool to guide lymphoma treatment in the future.
Circulating Tumor DNA in Lymphoma. [2023]Recent advances have been made in circulating tumor DNA (ctDNA), the method to minimally invasive detect lymphoma sensitively with tumor-derived DNA in the blood of patients with lymphomas. This article discusses these various methods of ctDNA detection and the clinical context in which they have been applied to for a variety of lymphoma subtypes.