Health Trials

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

ConditionsBladder CarcinomaUreter CarcinomaRenal Pelvis CarcinomaNon-small Cell Lung CancerInvasive Breast CarcinomaCutaneous MelanomaEsophageal CarcinomaGastroesophageal Junction CarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaSquamous Cell Carcinoma of the Head and NeckEpithelial Ovarian CarcinomaFallopian Tube CarcinomaEndometrial CarcinomaRenal Cell CarcinomaRectal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuardant Health, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Age > 18 years old AND

Initial treatment is given with curative/radical intent AND

Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND

Provided written informed consent to participate in the study AND

Disqualifiers

History of allogeneic organ or tissue transplant

Index cancer has predominantly neuroendocrine histology

History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral/multifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment

Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)

Trial design

Treatments tested in this trial

  • Guardant Reveal

Treatment groups

2,020 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Sponsors and collaborators

Guardant Health, Inc.

Lead sponsor

Source ClinicalTrials.gov