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RecruitingNCT07750886SCORE-NHLUpdated Aug 6, 2026

Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)

An observational study in Non-Hodgkin Lymphoma, T-Cell Lymphoma and Diffuse Large B-Cell Lymphoma, sponsored by Natera, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Natera, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • 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
  • Transformed Follicular Lymphoma
  • Follicular Lymphoma Grade 3B
  • Follicular Lymphoma
  • Anaplastic Large 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
03

In context

Lymphoma, Non-Hodgkin

2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.

This study's planned enrollment of 200 is above the median of 140 across 196 observational studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Natera, Inc. is the lead sponsor of 36 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants 18 years of age or older diagnosed with aggressive Stage I to IV non-Hodgkin lymphoma prior to receiving treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is at least 18 years of age or older.
  2. performance status ≤ 2.
  3. Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.
  4. 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.
  5. Patients who are planning to receive six cycles of therapy with an anthracycline-based chemotherapy regimen as per the standard of care.
  6. Radiographically 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).
  7. Able to tolerate blood draws according to Natera standard process.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.
  3. History of an stem cell transplant or other organ transplant.
  4. 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.
  5. Clinical ctDNA-MRD testing by any platform.
  6. Concurrent treatment that includes an agent.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 3 Years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07750886
Lead sponsor
Natera, Inc.
Responsible party
Sponsor
First posted
Aug 6, 2026
Start date
Jul 27, 2026 (estimated)
Primary completion
Apr 2032 (estimated)
Completion
Apr 2032 (estimated)
Last update
Aug 6, 2026

Study contacts

SCORE-NHL Study Team
Contact
contactscorenhlstudy@natera.com
650-489-9050

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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