NCT07750886 · Natera, Inc.
Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)
(SCORE-NHL)
What this study is about
The SCORE-NHL study is a forward-looking, multi-center, study designed to collect data and biological samples from participants diagnosed with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). Study participants will undergo research blood collections of up to 60 mL as well as residual tissue collection, collected as part of a the usual treatment procedure, for use in research.
View original scientific description
The SCORE-NHL study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). Study participants will undergo research blood collections of up to 60 mL as well as residual tissue collection, collected as part of a standard of care procedure, for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays ("Natera cancer monitoring and detection test(s)").
Primary outcome measures
Primary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Blood-Based Cancer Monitoring and Detection and Cancer Assay Development.
Time frame: 3 Years
The primary outcome is the collection of clinically characterized, de-identified whole blood and residual tissue specimens from 160 completed participants newly diagnosed with cancer. The data and specimens will be used for the development and validation of blood-based cancer monitoring and detection assays.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is at least 18 years of age or older.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.
- Patients with a new diagnosis of Stage I to IV aggressive non-Hodgkin lymphoma (NHL) including all aggressive large B-cell lymphoma (DLBCL, HGBCL, PMBCL), T-cell lymphoma (PTCL, ALCL), follicular lymphoma (FL) grade 3B, or transformed FL.
- Patients who are planning to receive six cycles of first-line therapy with an anthracycline-based chemotherapy regimen as per the standard of care.
- Radiographically measurable disease with at least one hypermetabolic lesion by Lugano classification on baseline FDG PET/CT or FDG PET (radiographically measurable disease by CT with intravenous contrast is allowed if FDG-PET/CT is not available).
- Able to tolerate blood draws according to Natera standard process.
Exclusion criteria
- Diagnosis of an indolent lymphoma that does not require immediate intervention, Hodgkin lymphoma, small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL). Other NHL diagnoses beyond DLBCL, aggressive TCLs, and grade 3B or transformed FL.
- Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.
- History of an allogeneic stem cell transplant or other organ transplant.
- Prior history and treatment for any cancer within the past year or another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.
- Clinical ctDNA-MRD testing by any platform.
- Concurrent treatment that includes an investigational agent.
Where
- Austin, Texas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations