ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

ConditionsBladder 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

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

Treatment groups

See each treatment group below.

Locations

France

CHU Besançon25000, Besançon France

Hôpital Franco-Britannique92300, Levallois-Perret France

Institut Paoli-Calmettes13009, Marseille France

Ambroise Paré-Hartmann92200, Neuilly France

Sponsors and collaborators

Guardant Health, Inc.

Lead sponsor

Source ClinicalTrials.gov