ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
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.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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 Exploratory Cohorts - 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 stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology), - Cohort 10: High-risk endometrial carcinoma (Defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)), - 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
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) - Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III) |
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| Cohort 2: Non-small cell lung cancer (stage IB-III) |
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| 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) |
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| Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma |
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| Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III) |
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| Cohort 6: Gastric adenocarcinoma (stage II-III) |
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| Cohort 7: Pancreatic adenocarcinoma | That is has been surgically resected or is eligible for surgical resection |
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| 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 |
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| Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma | Defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology). |
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| Cohort 10: High-risk endometrial carcinoma | Defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology). |
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| 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. |
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| 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 |
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Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35205
Birmingham, Alabama 35205
Contact:
Susan Binkley
Susan Binkley
More Details
- Status
- Recruiting
- Sponsor
- Guardant Health, Inc.