ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Guardant Health

Status: Enrolling

Conditions: Rectal Adenocarcinoma; Pancreatic Adenocarcinoma; Bladder Carcinoma; Gastroesophageal Junction Carcinoma; Fallopian Tube Carcinoma; Epithelial Ovarian Carcinoma; Renal Pelvis Carcinoma; Gastric Adenocarcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Ureter Carcinoma; Invasive Breast Carcinoma; Squamous Cell Carcinoma of the Head and Neck; Non-small Cell Lung Cancer; Renal Cell Carcinoma; Cutaneous Melanoma

Treatments: Diagnostic Test: Guardant Reveal

Study type: Observational

Funder types: Industry

Identifiers

NCT05059444

02-MX-003

Details and patient eligibility

About

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.

Enrollment: 2,020 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

2,020 participants in 12 patient groups

Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 2: Non-small cell lung cancer (stage IB-III)

Description:

Cohort 2A: Resectable Cohort 2B: Unresectable

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status

Description:

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)

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 6: Gastric adenocarcinoma (stage II-III)

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 7: Pancreatic adenocarcinoma

Description:

That is has been surgically resected or is eligible for surgical resection

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 8: Invasive squamous cell carcinoma of the head and neck

Description:

Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma

Description:

Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology.

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 10: High-risk endometrial carcinoma

Description:

Defined as FIGO stage II-III.

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 11: High-risk renal cell carcinoma

Description:

Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent.

Treatment:

Diagnostic Test: Guardant Reveal

Cohort 12: Pathologically confirmed adenocarcinoma of the rectum

Description:

Located up to 15 cm from the anal verge that is undergoing or underwent a preoperative chemotherapy- or immunotherapy-containing regimen