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NCT Number: NCT07318051

Sample Collection for Ongoing Research and Product Evaluation 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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GastroEsophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Muscle Invasive Bladder Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Natera, Inc.

Austin, Texas, 78753, United States

Location status: Recruiting

Location contact

Jamie McKenzie, MD

CONTACT

[email protected]

650-489-9050

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Secondary Outcome - Collection of Blood and Residual Tissue Specimens for Disease 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 disease assays.

Study contacts

Contact information is provided by the study sponsor or research team.

SCORE Study team

CONTACT

[email protected]

650-489-9050

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Registry information

Official study title

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

Acronym: SCORE

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Jan 5, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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