ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Overview

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.

Interventions

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

Primary outcome measures

• Distant Recurrence Free Interval (D-RFi) [Time frame: 3 years]

Secondary outcome measures (3)

• Sensitivity [Time frame: 3 years]
• Positive Predictive Value [Time frame: 3 years]
• Lead Time [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• 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
• Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND
• Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND
• Have at least one Landmark blood sample

Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts

• Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
• Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):

Cohort 2A: Resectable OR Cohort 2B: Unresectable,

• Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:

Cohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive/HER2-negative invasive breast carcinoma,

• Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,
• Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),
• Cohort 6: Gastric adenocarcinoma (stage II-III),
• Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,
• Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers),
• Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),
• Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),
• Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)

Exploratory Cohort

• Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 33 centers

• University of Alabama at Birmingham — Birmingham
• Ironwood Cancer & Research Centers — Chandler
• Genesis Cancer Center — Hot Springs
• University of California, San Diego — La Jolla
• Hoag Memorial Hospital Presbyterian — Newport Beach
• Redwood City — Redwood City
• Sutter Institute for Medical Research — Sacramento
• University of Colorado — Aurora
• … and 25 more centers

Spain · 13 centers

• Hospital Teresa Herrera (C.H.U.A.C) — A Coruña
• Vall Hebron Institute of Oncology — Barcelona
• Hospital Clinic of Barcelona — Barcelona
• ICO Institut Catala d'Oncologia — Barcelona
• Instituto Catalan de Oncologia de Girona — Girona
• Hospital Universitario Insular de Gran Canaria — Las Palmas de Gran Canaria
• Hospital San Carlos — Madrid
• Hospital Universitario La Paz — Madrid
• … and 5 more centers

France · 5 centers

• CHU Besançon — Besançon
• Hôpital Franco-Britannique — Levallois-Perret
• Institut Paoli-Calmettes — Marseille
• Ambroise Paré-Hartmann — Neuilly
• APHP Tenon Hospital - Sorbonne — Paris

Germany · 3 centers

• Asklepios Klinik Altona — Hamburg
• SLK-Kliniken Heilbronn GmbH — Heilbronn
• Ludwig Maximilian University Munich — Munich

Italy · 3 centers

• Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrL — Meldola
• Azienda USL-IRCCS di Reggio Emilia — Reggio Emilia
• Policlinico Universitario Agostino Gemelli — Roma

Identifiers

NCT: NCT05059444 · 02-MX-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗