Breast CancerSCORENCT07318051
Sample Collection for Ongoing Research and Product Evaluation Study
An observational study of Breast Cancer and Lung Cancer, run by Natera, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Muscle Invasive Bladder Cancer
- How many people
- 9,600 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants 18 years of age or older diagnosed with malignant, invasive solid tumors prior to receiving treatment.
Who may be able to join
- 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
Show all 20Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Natera, Inc.
Austin, Texas, 78753
Jamie McKenzie, MD, 650-489-9050, contactscorestudy@natera.com
About this study
Official title: Sample Collection for Ongoing Research and Product Evaluation (SCORE) Study
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.
Read the detailed description
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.
Participants who meet eligibility criteria for the SCORE study will be invited to enroll and must provide written informed consent prior to undergoing any study procedures. Participants will provide study-specific blood samples.
The SCORE study includes three participant cohorts:
- Cohort A - Surgical with Curative Intent
- Cohort B - Neoadjuvant Therapy
- Cohort C - Metastatic/No Surgery
Participants may be followed for up to eight years. 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. Participants will have data-only follow-up visits at one and five years after the final blood collection.
Tissue Sample Collection Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.
- Conditions
- Breast Cancer, Lung Cancer, Muscle Invasive Bladder Cancer, Rectal Cancer, Pancreatic Cancer, Ovarian Cancer
- Keywords
- Breast cancer, Lung cancer, Muscle invasive bladder cancer, Rectal cancer, Pancreatic cancer, Ovarian cancer, Gastroesophageal cancer, Prostate cancer, Melanoma, Head and Neck cancer, Uterine cancer, Liver cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Rectal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Melanoma, Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Collection of Blood and Residual Tissue Specimens for Cancer Assay Development
To collect de-identified whole blood and residual tissue specimens for research use and the development of blood-based cancer monitoring and detection assays.
Measured: 8 years
Secondary outcomes (1)
Secondary Outcome - Collection of Blood and Residual Tissue Specimens for Disease Assay Development
To collect de-identified whole blood and residual tissue specimens for research use and the development of blood-based disease assays.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start21 Jul 2025
- Primary completionJan 2035 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318051
- Sponsor's protocol ID
- 25-081-NCP
- Acronym
- SCORE
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Collection for Ongoing Research and Product Evaluation (SCORE) Study
- ClinicalTrials.gov ID
- NCT07318051
- Acronym / sponsor ID
- SCORE / 25-081-NCP
- Conditions
- Breast Cancer, Lung Cancer, Muscle Invasive Bladder Cancer, Rectal Cancer, Pancreatic Cancer, Ovarian Cancer
- Keywords
- Breast cancer, Lung cancer, Muscle invasive bladder cancer, Rectal cancer, Pancreatic cancer, Ovarian cancer, Gastroesophageal cancer, Prostate cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,600 participants (estimated)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Participants who meet eligibility criteria for the SCORE study will be invited to enroll and must provide written informed consent prior to undergoing any study procedures. Participants will provide study-specific blood samples.
The SCORE study includes three participant cohorts:
- Cohort A - Surgical with Curative Intent
- Cohort B - Neoadjuvant Therapy
- Cohort C - Metastatic/No Surgery
Participants may be followed for up to eight years. 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. Participants will have data-only follow-up visits at one and five years after the final blood collection.
Tissue Sample Collection Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants 18 years of age or older diagnosed with malignant, invasive solid tumors prior to receiving treatment.
Key inclusion criteria (20 listed)
- 18 years of age or older.
- Any patient that has an untreated primary solid malignancy within the following cohorts:
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome - Collection of Blood and Residual Tissue Specimens for Cancer Assay Development
Time frame: 8 years
To collect de-identified whole blood and residual tissue specimens for research use and the development of blood-based cancer monitoring and detection assays.
1 secondary outcome
Secondary Outcome - Collection of Blood and Residual Tissue Specimens for Disease Assay Development
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Natera, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SCORE Study team (650-489-9050, contactscorestudy@natera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome - Collection of Blood and Residual Tissue Specimens for Cancer Assay Development (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.