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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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676450
Collaborator
(none)
517
Enrollment
1
Location
1
Arm
16
Anticipated Duration (Months)
32.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: cell-free DNA
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
517 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official 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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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)

Diagnostic Test: cell-free DNA
Given by IV (vein)

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS) [through study completion; an average 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Christopher Flowers, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05676450
Other Study ID Numbers:
  • 2022-0603
  • NCI-2022-10562
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Neoplasm, Residual

Study Results

No Results Posted as of Jan 9, 2023