Recruiting

MRD Testing

Sponsor:

Natera, Inc.

Code:

NCT07318051

Conditions

Breast Cancer

Lung Cancer

Muscle Invasive Bladder Cancer

Rectal Cancer

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Lung Cancer

Muscle Invasive Bladder Cancer

Rectal Cancer

Pancreatic Cancer

Study ID

NCT07318051

Start date

Jul 21, 2025

Status verified date

Dec, 2025

Completion date

Jan, 2035

Anticipated

Primary completion date

Jan, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

9600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Primary Outcome - Collection of Blood and Residual Tissue Specimens for Cancer Assay Development [ Time Frame: 8 years ]

Central Contacts and Locations

Central contacts

Locations

Natera, Inc.

Recruiting

Austin, Texas, United States, 78753

Contacts

More Information

Sponsor

Natera, Inc.

Last update posted

Jan 15, 2026

Last verified

Dec, 2025

Keywords

  • Breast cancer
  • Lung cancer
  • Muscle invasive bladder cancer
  • Rectal cancer
  • Pancreatic cancer
  • Ovarian cancer
  • Gastroesophageal cancer
  • Prostate cancer
  • Melanoma
  • Head and Neck cancer
  • Uterine cancer
  • Liver cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Natera, Inc. on 2026-01-15.