Recruiting
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Condition(s) studied
Bladder 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 AdenocarcinomaColon Adenocarcinoma
Investigational drug(s) / intervention(s)
Guardant Reveal
Guardant Reveal: Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Study 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
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 3 years as outlined in the study protocol and informed consent AND
* Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen
* 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: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive 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, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),
* Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),
* Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)
* Cohort 12: Colorectal adenocarcinoma Cohort 12A: 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 OR Cohort 12B: Colon adenocarcinoma (stage II-III)
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 (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), 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)
Primary outcome measure(s)
- Distant Recurrence Free Interval (D-RFi) — 3 years
The primary endpoint, distant recurrence-free interval (D-RFi), will be evaluated for each of the primary study cohorts. D-RFi is defined as the time from the end of primary treatment until the time of diagnosis of a distant recurrence of the Index Cancer. Subjects without a distant recurrence will be censored at the time of last follow-up of their Index Cancer.
Trial sites (57)
| Facility | City | Region | Status |
| University of Alabama at Birmingham |
Birmingham |
Alabama |
Recruiting |
| Ironwood Cancer & Research Centers |
Chandler |
Arizona |
Recruiting |
| Genesis Cancer Center |
Hot Springs |
Arkansas |
Terminated |
| University of California, San Diego |
La Jolla |
California |
Recruiting |
| Hoag Memorial Hospital Presbyterian |
Newport Beach |
California |
Recruiting |
| Redwood City |
Redwood City |
California |
Recruiting |
| Sutter Institute for Medical Research |
Sacramento |
California |
Terminated |
| University of Colorado |
Aurora |
Colorado |
Recruiting |
| Memorial Healthcare System |
Hollywood |
Florida |
Recruiting |
| The Oncology Institute of Hope & Innovation |
Lakeland |
Florida |
Recruiting |
| Tulane Cancer Center |
New Orleans |
Louisiana |
Recruiting |
| Christus Highland/ Boniol |
Shreveport |
Louisiana |
Recruiting |
| Central Maine Medical Center |
Lewiston |
Maine |
Terminated |
| Massachusetts General Hospital |
Boston |
Massachusetts |
Terminated |
| Cancer & Hematology Centers of Western Michigan |
Grand Rapids |
Michigan |
Recruiting |
| Mayo Clinic (Rochester) |
Rochester |
Minnesota |
Recruiting |
| Astera Cancer Care |
East Brunswick |
New Jersey |
Recruiting |
| Icahn School of Medicine at Mount Sinai |
New York |
New York |
Terminated |
| UNC- Chapel Hill |
Chapel Hill |
North Carolina |
Recruiting |
| The Christ Hospital Cancer Center |
Cincinnati |
Ohio |
Terminated |
| Cleveland Clinic |
Cleveland |
Ohio |
Recruiting |
| Toledo Clinic Cancer Center |
Toledo |
Ohio |
Recruiting |
| Crozer-Keystone Health System |
Broomall |
Pennsylvania |
Terminated |
| University of Pennsylvania |
Philadelphia |
Pennsylvania |
Recruiting |
| WellSpan Medical Oncology & Hematology at York Cancer Center |
York |
Pennsylvania |
Recruiting |
| Carolina Urologic Research Center |
Myrtle Beach |
South Carolina |
Recruiting |
| Carolina Blood and Cancer Care Associates |
Rock Hill |
South Carolina |
Terminated |
| UT Southwestern Medical Center |
Dallas |
Texas |
Recruiting |
| DHR Health Advance Care Center |
Edinburg |
Texas |
Recruiting |
| The Center for Cancer and Blood Disorders |
Forth Worth |
Texas |
Recruiting |
| The University of Texas Health Science Center at San Antonio |
San Antonio |
Texas |
Recruiting |
| Utah Cancer Specialists |
Salt Lake City |
Utah |
Recruiting |
| ThedaCare Regional Cancer Center |
Appleton |
Wisconsin |
Recruiting |
| CHU Besançon |
Besançon |
France |
Recruiting |
| Hôpital Franco-Britannique |
Levallois-Perret |
France |
Recruiting |
| Institut Paoli-Calmettes |
Marseille |
France |
Recruiting |
| Ambroise Paré-Hartmann |
Neuilly |
France |
Recruiting |
| APHP Tenon Hospital - Sorbonne |
Paris |
France |
Recruiting |
| Asklepios Klinik Altona |
Hamburg |
Germany |
Recruiting |
| SLK-Kliniken Heilbronn GmbH |
Heilbronn |
Germany |
Recruiting |
+ 17 more sites — see the full list on the official registry below.