ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 7, 2021

Status verified

Aug 2025

Primary completion

Aug 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

2,020 participants (estimated)

Arms

• Arm: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
• Arm: Cohort 2: Non-small cell lung cancer (stage IB-III)
  Cohort 2A: Resectable Cohort 2B: Unresectable
• Arm: 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)
• Arm: Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
• Arm: Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
• Arm: Cohort 6: Gastric adenocarcinoma (stage II-III)
• Arm: Cohort 7: Pancreatic adenocarcinoma
  That is has been surgically resected or is eligible for surgical resection
• Arm: 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
• Arm: 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.
• Arm: Cohort 10: High-risk endometrial carcinoma
  Defined as FIGO stage II-III.
• Arm: 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.
• Arm: 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

Primary Outcome Measure

Distant Recurrence Free Interval (D-RFi) [ Time Frame: 3 years ]

Central Contacts

• Clinical Trial Operations
  8556988887
  [email protected]

Locations (33)

Find similar trials in Birmingham, AL

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