Clinical Trials

Clinical Trials

Clinical Trial Number: SCORE
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Sample Collection for Ongoing Research and Product Evaluation Study

Study ID: SCORE
Phase N/A
Physician Investigator(s)
Study Locations

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484.476.2649
cancertrials@mlhs.org

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.

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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

  1. The participant has a suspected primary malignancy of pancreatic, endometrial, bladder, or ovarian cancer based on imaging.
  2. Eastern Cooperative Oncology Group performance status ≤ 2.
  3. Able to tolerate venipuncture for research blood draw(s).
  4. Consent to provide residual tumor tissue for research.
  5. Willing and able to comply with the study requirements.
  6. 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.