ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Status: Recruiting
Location: See all (57) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
Genesis Cancer Center
TERMINATED
Hot Springs
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
California
University of California, San Diego
RECRUITING
La Jolla
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Redwood City
RECRUITING
Redwood City
Sutter Institute for Medical Research
TERMINATED
Sacramento
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Memorial Healthcare System
RECRUITING
Hollywood
The Oncology Institute of Hope & Innovation
RECRUITING
Lakeland
Louisiana
Tulane Cancer Center
RECRUITING
New Orleans
Christus Highland/ Boniol
RECRUITING
Shreveport
Massachusetts
Massachusetts General Hospital
TERMINATED
Boston
Maine
Central Maine Medical Center
RECRUITING
Lewiston
Michigan
Cancer & Hematology Centers of Western Michigan
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic (Rochester)
RECRUITING
Rochester
North Carolina
UNC- Chapel Hill
RECRUITING
Chapel Hill
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
New York
Icahn School of Medicine at Mount Sinai
TERMINATED
New York
Ohio
The Christ Hospital Cancer Center
TERMINATED
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Toledo Clinic Cancer Center
RECRUITING
Toledo
Pennsylvania
Crozer-Keystone Health System
TERMINATED
Broomall
University of Pennsylvania
RECRUITING
Philadelphia
Cancer Care Associates of York
RECRUITING
York
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Carolina Blood and Cancer Care Associates
RECRUITING
Rock Hill
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
DHR Health Advance Care Center
RECRUITING
Edinburg
The Center for Cancer and Blood Disorders
RECRUITING
Forth Worth
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Utah
Utah Cancer Specialists
RECRUITING
Salt Lake City
Wisconsin
ThedaCare Regional Cancer Center
RECRUITING
Appleton
Other Locations
France
CHU Besançon
RECRUITING
Besançon
Hôpital Franco-Britannique
RECRUITING
Levallois-perret
Institut Paoli-Calmettes
RECRUITING
Marseille
Ambroise Paré-Hartmann
RECRUITING
Neuilly
APHP Tenon Hospital - Sorbonne
RECRUITING
Paris
Germany
Asklepios Klinik Altona
RECRUITING
Hamburg
SLK-Kliniken Heilbronn GmbH
RECRUITING
Heilbronn
Ludwig Maximilian University Munich
RECRUITING
Munich
Italy
Instituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST, SrL
RECRUITING
Meldola
Azienda USL-IRCCS di Reggio Emilia
RECRUITING
Reggio Emilia
Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Spain
Hospital Teresa Herrera (C.H.U.A.C)
RECRUITING
A Coruña
Hospital Clinic of Barcelona
RECRUITING
Barcelona
ICO Institut Catala d'Oncologia
RECRUITING
Barcelona
Vall Hebron Institute of Oncology
RECRUITING
Barcelona
Instituto Catalan de Oncologia de Girona
RECRUITING
Girona
Hospital Universitario Insular de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
CIOSS HM Sanchinarro
RECRUITING
Madrid
Hospital San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
CCS Hospital Universitari Parc Taulí
RECRUITING
Sabadell
Hospital Clinico de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Clínico de Valencia
RECRUITING
Valencia
Contact Information
Primary
Clinical Trial Operations
mrdoraclestudy@guardanthealth.com
8556988887
Time Frame
Start Date: 2021-09-07
Estimated Completion Date: 2029-08
Participants
Target number of participants: 2020
Treatments
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
Cohort 2: Non-small cell lung cancer (stage IB-III)
Cohort 2A: Resectable Cohort 2B: Unresectable
Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status
Cohort 3A: High-risk HER2+ breast cancer (any ER, PR status allowed); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3B: High-risk triple negative breast cancer (TNBC); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3C: HR-positive/HER2-negative invasive breast carcinoma with either \>4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes and at least one of the following: tumor size \>5 cm, histologic grade 3, or validated gene expression assay indicating high recurrence risk (OncotypeDx score \> 26, MammaPrint high, ProSigna high, EndoPredict high)
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
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, or paranasal sinus
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 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.
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
Sponsors
Leads: Guardant Health, Inc.

This content was sourced from clinicaltrials.gov

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