Non-Hodgkin LymphomaSCORE-NHLNCT07750886
Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)
An observational study of Non-Hodgkin Lymphoma and T-Cell Lymphoma, run by Natera, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma, T-Cell Lymphoma, Diffuse Large B-Cell Lymphoma
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to Apr 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants 18 years of age or older diagnosed with aggressive Stage I to IV non-Hodgkin lymphoma prior to receiving treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Natera, Inc.
Austin, Texas, 78753
Radhakrishnan Ramchandren, MD, 650-489-9050
About this study
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)").
Read the detailed description
The study is designed to evaluate the clinical performance of Natera's molecular residual disease (MRD) assays in detecting ctDNA in patients with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). The goal is to assess the ability of the assay to identify minimal residual disease, monitor disease recurrence, and evaluate treatment response following standard-of-care therapy. No individual test results from the study testing will be provided to participants or their treating clinicians.
Participants who meet the study inclusion criteria will be invited to enroll in the study. Informed consent form (ICF) (paper or electronic) will be signed by the participant prior to study procedures. Participants will provide study-specific blood samples.
Participants may be followed for up to three years. During the first two years, blood samples will be collected at protocol-defined timepoints. Participants will then complete one year of data-only follow-up.
Tissue Sample Collection Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.
- Conditions
- Non-Hodgkin Lymphoma, T-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphoma, Primary Mediastinal B-Cell Lymphoma, Peripheral T-Cell Lymphoma
- Keywords
- Non-Hodgkin Lymphoma, T-Cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal B-Cell Lymphoma, Peripheral T-Cell Lymphoma, Anaplastic Large Cell Lymphoma, Transformed Follicular Lymphoma, Follicular Lymphoma grade 3B, Follicular Lymphoma, NHL, DLBCL, HGBCL, High-Grade B-Cell Lymphoma, PMBCL, PTCL, FL, ALCL
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell, Peripheral, Lymphoma, Follicular, Lymphoma, Large-Cell, Anaplastic
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Blood-Based Cancer Monitoring and Detection and Cancer Assay Development.
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.
Measured: 3 Years
Secondary outcomes (1)
Secondary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Disease Assay Development for Blood-Based Cancer Monitoring and Detection.
The secondary outcome is to collect 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 a broader range of blood-based disease monitoring assays.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start27 Jul 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750886
- Sponsor's protocol ID
- 25-097-NCP
- Acronym
- SCORE-NHL
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No