ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
a study on Bladder Cancer Ureteral Cancer Renal Pelvis Carcinoma Lung Cancer Non-Small Cell Lung Cancer Breast Cancer Skin Cancer/Melanoma Esophageal Cancer Gastroesophageal Junction Cancer Gastric Adenocarcinoma Stomach Cancer Pancreatic Cancer Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Ovarian Cancer Fallopian Tube Cancer Endometrial Cancer Kidney Cancer Renal Cell Carcinoma Colorectal Cancer Rectal Cancer Urinary Bladder Tumor Ovarian Epithelial Carcinoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedstudy ends around
Description
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.
Keywords
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, Urinary Bladder Neoplasms, Ureteral Neoplasms, Non-Small-Cell Lung Carcinoma, Cutaneous Malignant Melanoma, Esophageal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Ovarian Epithelial Carcinoma, Fallopian Tube Neoplasms, Endometrial Neoplasms, Rectal Neoplasms, Guardant Reveal, Invasive squamous cell carcinoma of the head and neck, Pathologically confirmed adenocarcinoma of the rectum
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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)
Locations
- University of California, San Diego
accepting new patients
La Jolla 5363943 California 5332921 92093 United States - Hoag Memorial Hospital Presbyterian
accepting new patients
Newport Beach 5376890 California 5332921 92663 United States - Sutter Institute for Medical Research
terminated
Sacramento 5389489 California 5332921 95816 United States - Redwood City
accepting new patients
Redwood City 5386834 California 5332921 94063 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Guardant Health, Inc.
- ID
- NCT05059444
- Study Type
- Observational
- Participants
- Expecting 2020 study participants
- Last Updated