Sample Collection for Ongoing Research and Product Evaluation Study (SCORE)

January 13, 2026 updated by: Natera, Inc.

Sample Collection for Ongoing Research and Product Evaluation (SCORE) Study

The SCORE study is a prospective, multi-site clinical trial designed to collect blood and tissue samples, along with relevant clinical data, from participants diagnosed with various solid tumors. The collected specimens and information will be used to evaluate the clinical performance of Natera's molecular residual disease (MRD) testing across multiple cancer types. The study aims to assess the ability of Natera's assays to detect circulating tumor DNA (ctDNA) as a marker for disease recurrence and treatment response.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study is designed to evaluate the clinical performance of Natera's molecular residual disease (MRD) assays in detecting ctDNA across multiple solid tumor types. 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 eligibility criteria for the SCORE study will be invited to enroll and must provide written informed consent prior to undergoing any study procedures. Participants will provide study-specific blood samples.

The SCORE study includes three participant cohorts:

  • Cohort A - Surgical with Curative Intent
  • Cohort B - Neoadjuvant Therapy
  • Cohort C - Metastatic/No Surgery

Participants may be followed for up to eight years. During the first three years, blood samples will be collected periodically, approximately every six weeks, for up to two years after surgery or completion of primary treatment. Participants will have data-only follow-up visits at one and five years after the final blood collection.

Tissue Sample Collection Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.

Study Type

Observational

Enrollment (Estimated)

9600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants 18 years of age or older diagnosed with malignant, invasive solid tumors prior to receiving treatment.

Description

Inclusion Criteria:

  1. 18 years of age or older.

  2. Any patient that has an untreated primary solid malignancy within the following cohorts:

    1. Breast cancer
    2. Lung cancer
    3. Muscle invasive bladder cancer
    4. Rectal cancer
    5. Pancreatic cancer
    6. Ovarian cancer
    7. Gastroesophageal cancer
    8. Prostate cancer
    9. Melanoma
    10. Hepatic/liver cancer
    11. Uterine/endometrial cancer
    12. Head and neck Cancer
  3. The participant has a suspected primary malignancy of pancreatic, endometrial, bladder, or ovarian cancer based on imaging.
  4. Eastern Cooperative Oncology Group performance status ≤ 2.
  5. Able to tolerate venipuncture for research blood draw(s).
  6. Consent to provide residual tumor tissue for research.
  7. Willing and able to comply with the study requirements.
  8. Signed informed consent(s) must be obtained prior to participation in the study.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.
  3. Has initiated postoperative systemic treatment.
  4. At time of enrollment, has undergone or plans to undergo any ctDNA testing to assess molecular residual disease, with the exception of comprehensive genomic profiling for therapeutic selection.
  5. History of bone marrow or organ transplant.
  6. Serious medical conditions that may adversely affect ability to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome - Collection of Blood and Residual Tissue Specimens for Cancer Assay Development
Time Frame: 8 years
To collect de-identified whole blood and residual tissue specimens for research use and the development of blood-based cancer monitoring and detection assays.
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome - Collection of Blood and Residual Tissue Specimens for Disease Assay Development
Time Frame: 8 years
To collect de-identified whole blood and residual tissue specimens for research use and the development of blood-based disease assays.
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natera, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Estimated)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-081-NCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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