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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Natera, Inc.
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: SCORE Study team
• Email: contactscorestudy@natera.com
• Phone: 650-489-9050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.