ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 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 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, 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05059444
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guardant Health, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Study Director
Principal Investigator Affiliation	Guardant Health, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Germany, Italy, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Arms & Interventions

Arms

: 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

Interventions

Diagnostic Test: - Guardant Reveal

Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham 4049979, Alabama 4829764, 35205

Site Contact

Susan Binkley

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