Clinical trial NCT05059444: ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Official title: ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Guardant Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The primary study population will include participants with invasive bladder, ureteral, or renal pelvis carcinoma, NSCLC, or breast cancer as per inclusion/exclusion criteria defined below. Exploratory cohorts include participants with cutaneous melanoma, esophageal carcinoma, gastroesophageal junction carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, squamous cell carcinoma of the head and neck, epithelial ovarian/Fallopian tube carcinoma, endometrial cancer, renal cell carcinoma (RCC), and rectal adenocarcinoma as per inclusion/exclusion criteria below. Inclusion criteria were selected to enroll participants who are predicted to have \>15-20% risk of recurrence within 5 years in order to sufficiently power the study for recurrence events.

Brief 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.


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 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

Exploratory Cohorts

* 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 stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology),
* Cohort 10: High-risk endometrial carcinoma (Defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)),
* 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),
* 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)
* Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence

Primary outcomes:
measure: Distant Recurrence Free Interval (D-RFi)
timeFrame: 6 years
Secondary outcomes:
measure: Sensitivity
timeFrame: 6 years
measure: Positive Predictive Value
timeFrame: 6 years
measure: Lead Time
timeFrame: 6 years
Other outcomes:
measure: Recurrence-free interval (RFi)
timeFrame: 6 years
measure: Negative predictive value (NPV)
timeFrame: 6 years
measure: Association with resolution of indeterminate findings
timeFrame: 6 years
measure: Sensitivity for local recurrence
timeFrame: 6 years
measure: Index Cancer-Specific Survival (ICSS)
timeFrame: 6 years
measure: Overall Survival (OS)
timeFrame: 6 years
measure: Rate of ctDNA clearance with adjuvant chemotherapy
timeFrame: 6 years
measure: Association of ctDNA detection status with pathologic response
timeFrame: 6 years
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Redwood City
country: United States
facility: Redwood City
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Lakeland
country: United States
facility: The Oncology Institute of Hope & Innovation
state: Florida
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: Christus Highland/ Boniol
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic (Rochester)
state: Minnesota
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: UNC- Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Broomall
country: United States
facility: Crozer-Keystone Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Edinburg
country: United States
facility: DHR Health Advance Care Center
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Besançon
country: France
facility: CHU Besançon
city: Levallois-Perret
country: France
facility: Hôpital Franco-Britannique
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Neuilly
country: France
facility: Ambroise Paré-Hartmann
city: Paris
country: France
facility: APHP Tenon Hospital - Sorbonne
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Munich
country: Germany
facility: Ludwig Maximilian University Munich
city: Meldola
country: Italy
facility: Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS IRST, SrL
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: A Coruña
country: Spain
facility: Hospital Teresa Herrera (C.H.U.A.C)
city: Barcelona
country: Spain
facility: Vall Hebron Institute of Oncology
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Barcelona
country: Spain
facility: ICO Institut Catala d'Oncologia
city: Girona
country: Spain
facility: Instituto Catalan de Oncologia de Girona
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Madrid
country: Spain
facility: Hospital San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: CIOSS HM Sanchinarro
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sabadell
country: Spain
facility: CCS Hospital Universitari Parc Taulí
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico de Santiago de Compostela
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
Study officials:
affiliation: Guardant Health, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: