Sample Collection for Ongoing Research and Product Evaluation Study
Recruiting · NCT07318051 · Observational (researchers observe without assigning treatment) · Lead sponsor: Natera, Inc.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 18 years of age or older.
- Any patient that has an untreated primary solid malignancy within the following cohorts:
- Breast cancer
- Lung cancer
- Muscle invasive bladder cancer
- Rectal cancer
- Pancreatic cancer
- Ovarian cancer
- Gastroesophageal cancer
- Prostate cancer
- Melanoma
- Hepatic/liver cancer
- Uterine/endometrial cancer
- Head and neck Cancer
- The participant has a suspected primary malignancy of pancreatic, endometrial, bladder, or ovarian cancer based on imaging.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Able to tolerate venipuncture for research blood draw(s).
- Consent to provide residual tumor tissue for research.
- Willing and able to comply with the study requirements.
- Signed informed consent(s) must be obtained prior to participation in the study.
Exclusion criteria
- Pregnant or breastfeeding.
- 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.
- Has initiated postoperative systemic treatment.
- 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.
- History of bone marrow or organ transplant.
- Serious medical conditions that may adversely affect ability to participate in the study.
Where it is running
2 locations listed across 1 US state.
- Natera, Inc. - Austin, Texas, United States
- Natera, Inc. - Austin, Texas, United States