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Sample Collection for Ongoing Research and Product Evaluation Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will provide study-specific blood samples."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The SCORE study collects blood, tumor tissue, and health information from adults with certain solid tumors. It tests how well Natera’s tests find tiny bits of cancer DNA in the blood to help show if cancer has returned or how it responds to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have an untreated cancer that started in the breast, lung, rectum, pancreas, ovary, stomach or food pipe, prostate, liver, uterus, or head and neck; melanoma (a skin cancer); or bladder cancer that has grown into muscle.
  • Scans suggest cancer that started in the pancreas, lining of the uterus, bladder, or ovary.
  • You can care for yourself and are out of bed or a chair for more than half of your waking hours, even if you cannot work.
  • You can have blood drawn from a vein for research.
  • You agree to share leftover tumor tissue for research.
  • You are willing and able to follow the study requirements.
  • You sign forms agreeing to join before taking part.

Who can't join

  • You are pregnant or breastfeeding.
  • You had cancer and treatment for it within the past year, or have another active cancer. Surgically removed basal cell or squamous cell skin cancers are allowed.
  • You have started cancer treatment after surgery that works throughout the body.
  • When you join, you have had or plan to have a blood test for cancer DNA to check for tiny amounts of cancer left in the body. Broad gene testing to help choose treatment is allowed.
  • You have had a bone marrow or organ transplant.
  • You have a serious health condition that could make it hard to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX