Status:
RECRUITING
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Lead Sponsor:
Guardant Health, Inc.
Conditions:
Bladder Carcinoma
Ureter Carcinoma
Eligibility:
All Genders
18+ years
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
2020 Patients enrolled
Trial Details
Trial ID
NCT05059444
Start Date
September 7 2021
End Date
August 1 2029
Last Update
August 22 2025
Active Locations (57)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
2
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
3
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
4
University of California, San Diego
La Jolla, California, United States, 92093