ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

NCT05059444 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2020

Last updated 2025-08-22

No results posted yet for this study

Summary

The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

Conditions

  • Bladder Carcinoma
  • Ureter Carcinoma
  • Renal Pelvis Carcinoma
  • Non-small Cell Lung Cancer
  • Invasive Breast Carcinoma
  • Cutaneous Melanoma
  • Esophageal Carcinoma
  • Gastroesophageal Junction Carcinoma
  • Gastric Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Epithelial Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Endometrial Carcinoma
  • Renal Cell Carcinoma
  • Rectal Adenocarcinoma

Interventions

DIAGNOSTIC_TEST

Guardant Reveal

Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.

Sponsors & Collaborators

  • Guardant Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Guardant Health, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05059444 on ClinicalTrials.gov