- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05676450
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
Study Overview
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chijioke Nze, MD
- Phone Number: 832-729-1752
- Email: CCNze@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Md Anderson Cancer Center
-
Contact:
- Chijioke Nze, MD
- Phone Number: 832-729-1752
- Email: CCNze@mdanderson.org
-
Principal Investigator:
- Chijioke Nze, MD
-
San Antonio, Texas, United States, 78229
- Recruiting
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
-
Contact:
- Adolfo Enriques Diaz Duque, MD
- Phone Number: 210-450-1209
- Email: diazduque@uthscsa.edu
-
Principal Investigator:
- Adolfo Enriques Diaz Duque, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: cell-free DNA (cfDNA) samples
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) |
Given by IV (vein)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival (OS)
Time Frame: through study completion; an average 1 year
|
through study completion; an average 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chijioke Nze, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hemic and Lymphatic Diseases
- Lymphoma
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Cytological Techniques
- Biopsy
- Cytodiagnosis
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Genetic Testing
- Genetic Techniques
- Genetic Services
- Diagnostic Services
- Diagnostic Techniques, Obstetrical and Gynecological
- Liquid Biopsy
- Prenatal Diagnosis
- Noninvasive Prenatal Testing
Other Study ID Numbers
- 2022-0603
- NCI-2022-10562 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma
-
Marcela V. Maus, M.D.,Ph.D.RecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Non-Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Non-hodgkin Lymphoma | High-grade B-cell Lymphoma | Grade 3b Follicular Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
-
Novartis PharmaceuticalsBristol-Myers SquibbTerminatedNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaItaly, Singapore, Australia, China, Germany, South Korea, Japan
-
SymBio PharmaceuticalsCompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma | Lymphoma, Large Cell | Diffuse, Mantle Cell Lymphoma, Lymphoma | Large B-Cell, DiffuseJapan, Korea, Republic of
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Mantle Cell Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Refractory Marginal Zone Lymphoma | Recurrent Lymphoplasmacytic... and other conditionsUnited States, Canada
-
Robert LowskyNational Cancer Institute (NCI); Janssen, LP; The Leukemia and Lymphoma Society; Rising Tide FoundationCompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular LymphomaUnited States
-
Epizyme, Inc.CompletedFollicular Lymphoma | Marginal Zone Lymphoma | Advanced Solid Tumors | Mantle-Cell Lymphoma | Diffuse Large B Cell Lymphoma | Primary Mediastinal LymphomaUnited Kingdom
-
IGM Biosciences, Inc.ADC Therapeutics S.A.TerminatedFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCLUnited States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
-
Juno Therapeutics, a Subsidiary of CelgeneCompletedFollicular Lymphoma | Non-Hodgkin Lymphoma | Diffuse Large B Cell Lymphoma | Primary Mediastinal B-cell Lymphoma | Mantle-cell LymphomaUnited States
-
Lymphoma Study AssociationCompletedLymphoma, Large B-Cell, Diffuse | Follicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone LymphomaFrance
-
Emory UniversityNational Cancer Institute (NCI); AstraZenecaRecruitingMantle Cell Lymphoma | Marginal Zone Lymphoma | Lymphoplasmacytic Lymphoma | Lymphoproliferative Disorder | Indolent Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular LymphomaUnited States
Clinical Trials on cell-free DNA
-
Peking Union Medical College HospitalUnknown
-
University Health Network, TorontoThe Hospital for Sick Children; University of Alberta; Women's College Hospital; Jewish General Hospital and other collaboratorsRecruiting
-
Institut du Cancer de Montpellier - Val d'AurelleCompleted
-
Puerta de Hierro University HospitalRecruitingHeart Transplant RejectionSpain
-
Postgraduate Institute of Medical Education and...RecruitingHepatic Carcinoma Malignant Primary Non-ResectableIndia
-
Paris Translational Research Center for Organ TransplantationCompletedKidney Rejection Transplant
-
Puerta de Hierro University HospitalCompletedCardiac Allograft VasculopathySpain
-
Loma Linda UniversityRecruitingGraft Failure | Acute Rejection of Renal TransplantUnited States
-
Insight Molecular DiagnosticsRecruitingKidney Transplant Rejection | Cell-free DNAUnited States, Germany
-
Shanghai Changzheng HospitalNot yet recruitingUrinary Tract Infections | Sequelae of; Infection