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Trial Title:
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
NCT ID:
NCT05676450
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Neoplasm, Residual
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cell-free DNA
Description:
Given by IV (vein)
Arm group label:
cell-free DNA (cfDNA) samples
Summary:
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
Criteria for eligibility:
Criteria:
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.
4. Pregnant women not included
5. Cognitively impaired adults are not included.
Exclusion Criteria:
None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Flowers, MD
Phone:
713-745-6095
Email:
crflowers@mdanderson.org
Investigator:
Last name:
Christopher Flowers, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adolfo Enriques Diaz Duque, MD
Phone:
210-450-1209
Email:
diazduque@uthscsa.edu
Investigator:
Last name:
Adolfo Enriques Diaz Duque, MD
Email:
Principal Investigator
Start date:
February 23, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05676450
http://www.mdanderson.org
