NCT07318051

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,600

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2025Jan 2035

Study Start

First participant enrolled

July 21, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

9.5 years

First QC Date

December 19, 2025

Last Update Submit

January 13, 2026

Conditions

Breast CancerLung CancerMuscle Invasive Bladder CancerRectal CancerPancreatic CancerOvarian CancerGastroesophageal CancerProstate CancerMelanomaUterine CancerLiver CancerHead and Neck Cancer

Keywords

Breast cancerLung cancerMuscle invasive bladder cancerRectal cancerPancreatic cancerOvarian cancerGastroesophageal cancerProstate cancerMelanomaHead and Neck cancerUterine cancerLiver cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 years

Secondary Outcomes (1)

  • Secondary Outcome - Collection of Blood and Residual Tissue Specimens for Disease Assay Development

    8 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants 18 years of age or older diagnosed with malignant, invasive solid tumors prior to receiving treatment.

You may qualify if:

  • 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.
  • +5 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natera, Inc.

Austin, Texas, 78753, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and tissue samples

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsRectal NeoplasmsPancreatic NeoplasmsOvarian NeoplasmsProstatic NeoplasmsMelanomaHead and Neck NeoplasmsUterine NeoplasmsLiver Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsUterine DiseasesLiver Diseases

Central Study Contacts

SCORE Study team

CONTACT

650-489-9050contactscorestudy@natera.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

July 21, 2025

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2035

Last Updated

January 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)