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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)
- ClinicalTrials.gov ID
- NCT07750886
- Acronym / sponsor ID
- SCORE-NHL / 25-097-NCP
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)").
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Secondary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Disease Assay Development for Blood-Based Cancer Monitoring and Detection.
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma and T-Cell Lymphoma, run by Natera, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SCORE-NHL Study Team (650-489-9050, contactscorenhlstudy@natera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.