RecruitingNCT05059444
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Sponsor
Guardant Health, Inc.
Enrollment
2,020 participants
Start Date
Sep 7, 2021
Study Type
OBSERVATIONAL
Conditions
Bladder CarcinomaEsophageal CarcinomaNon-small Cell Lung CancerRenal Cell CarcinomaInvasive Breast CarcinomaUreter CarcinomaRenal Pelvis CarcinomaCutaneous MelanomaGastroesophageal Junction CarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaSquamous Cell Carcinoma of the Head and NeckEpithelial Ovarian CarcinomaFallopian Tube CarcinomaEndometrial CarcinomaRectal Adenocarcinoma
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
Min Age: 18 Years
Inclusion Criteria24
- 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 Criteria4
- 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)
Interventions
DIAGNOSTIC_TESTGuardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Locations(57)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05059444
Related Trials
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT07195695192 locations
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
NCT074546422 locations
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
NCT0711504311 locations
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
NCT06712316184 locations
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT0360696730 locations