Collecting blood and leftover tumor tissue to test molecular residual disease (MRD) detection

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

This project will test whether blood and leftover tumor tissue from adults with certain solid tumors can be used with Natera's MRD blood tests to find tiny amounts of cancer (ctDNA) after treatment.

Quick facts

• Study type: Observational
• Enrollment: 9600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Natera, Inc. (industry)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT07318051 on ClinicalTrials.gov

What this trial studies

This is a prospective cohort study that enrolls adults with a range of untreated primary solid tumors and collects serial blood samples plus residual tumor tissue from standard-of-care procedures. Participants are assigned to one of three cohorts (surgery with curative intent, neoadjuvant therapy, or metastatic/no surgery) and will provide blood roughly every six weeks for up to two years after surgery or completion of primary treatment, with data-only follow-up visits later. The collected specimens and clinical data will be used to apply Natera's molecular residual disease (MRD) assays to detect circulating tumor DNA (ctDNA) for monitoring minimal residual disease, recurrence, and treatment response. Individual study test results will not be returned to participants or their treating clinicians.

Who should consider this trial

Good fit: Adults (18+) with an untreated primary solid malignancy in the listed tumor types, ECOG performance status 0–2, who can tolerate blood draws, consent to provide residual tumor tissue, and agree to follow-up visits are ideal candidates.

Not a fit: Pregnant or breastfeeding individuals, people with prior treated cancers excluded by the protocol, or patients who need individual test results for immediate clinical decisions may not receive direct benefit from participation.

Why it matters

Potential benefit: If successful, this approach could enable earlier detection of recurrence and better-tailored follow-up care using a simple blood test.

How similar studies have performed: Similar ctDNA MRD approaches have shown promising results in some cancers (for example colorectal), but broader multi-cancer utility is still being tested.

Eligibility criteria

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.

Where this trial is running

Austin, Texas

• Natera, Inc. — Austin, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: SCORE Study team

Conditions: Breast Cancer, Lung Cancer, Muscle Invasive Bladder Cancer, Rectal Cancer, Pancreatic Cancer, Ovarian Cancer, Gastroesophageal Cancer, Prostate Cancer