Guardant Reveal for Cancer

(ORACLE Trial)

Recruiting at 53 trial locations

Overseen By Clinical Trial Operations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Guardant Health, Inc.

Disqualifiers: Organ transplant, Neuroendocrine cancer, Metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2020 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new blood test, the ctDNA assay (Guardant Reveal), can detect cancer recurrence after treatment for early-stage solid tumors. It evaluates the test's effectiveness across various cancers, including certain types of breast, lung, and pancreatic cancers. Suitable participants have completed treatments for these cancers and plan regular follow-ups to monitor for recurrence. The trial seeks participants willing to provide blood samples and share clinical data over several years. As a Phase 2 trial, this research focuses on assessing the test's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in cancer detection.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Guardant Reveal ctDNA assay is safe for detecting recurrence in early-stage solid tumors?

Research shows that tests like Guardant Reveal and Guardant360 CDx are generally well-tolerated. These tests analyze tiny DNA fragments in the blood and have been used safely in other contexts. No major safety issues have been reported, indicating that patients usually do not experience serious side effects. Although Guardant Reveal is relatively new, it relies on technology already approved by the FDA for other uses, suggesting it is likely safe due to its foundation on a trusted method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ORACLE trial because it uses liquid biopsy technology, specifically Guardant Reveal, to monitor residual cancer in patients. Unlike traditional biopsies, which are invasive and can be uncomfortable, liquid biopsies are non-invasive and involve analyzing a simple blood sample to detect cancer DNA. This method provides a quicker, less invasive way to assess treatment efficacy and cancer recurrence. By potentially offering real-time insights, it could significantly improve how doctors monitor cancer progression and adjust treatments, making it a promising advancement in cancer care.

What evidence suggests that the Guardant Reveal ctDNA assay is effective for detecting recurrence in early-stage solid tumors?

Research has shown that Guardant Reveal, a blood test using circulating tumor DNA (ctDNA), can detect cancer at a very early stage. This test aims to catch cancer returning in individuals treated for solid tumors. In this trial, participants from various cohorts, including those with invasive breast carcinoma, pancreatic adenocarcinoma, and other cancers, will be monitored using Guardant Reveal. Studies have found that ctDNA reliably identifies minimal residual disease (MRD), helping to detect leftover cancer cells that might cause recurrence. This method is particularly beneficial because it is less invasive than traditional biopsy methods. Early results suggest that using ctDNA to detect recurrence might offer a more accurate way to monitor cancer patients after treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

Guardant Health, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Were treated with curative intent

Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site

Provided written informed consent to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Treatment

Participants undergo primary treatment for their respective cancer types

Varies by cohort

Observation

Participants are monitored using ctDNA assays to detect cancer recurrence

6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

What Are the Treatments Tested in This Trial?

Interventions

• Guardant Reveal

How Is the Trial Designed?

Group I: Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma Experimental Treatment 1 Intervention

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

Group II: Cohort 8: Invasive squamous cell carcinoma of the head and neck Experimental Treatment 1 Intervention

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

Group III: Cohort 7: Pancreatic adenocarcinoma Experimental Treatment 1 Intervention

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

Group IV: Cohort 6: Gastric adenocarcinoma (stage II-III) Experimental Treatment 1 Intervention

Group V: Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III) Experimental Treatment 1 Intervention

Group VI: Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma Experimental Treatment 1 Intervention

Group VII: Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status Experimental Treatment 1 Intervention

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)

Group VIII: Cohort 2: Non-small cell lung cancer (stage IB-III) Experimental Treatment 1 Intervention

Cohort 2A: Resectable Cohort 2B: Unresectable

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

Group X: Cohort 12: Pathologically confirmed adenocarcinoma of the rectum Experimental Treatment 0 Interventions

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

Group XI: Cohort 11: High-risk renal cell carcinoma Experimental Treatment 1 Intervention

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

Group XII: Cohort 10: High-risk endometrial carcinoma Experimental Treatment 1 Intervention

Defined as FIGO stage II-III.

Who Is Running the Clinical Trial?

Guardant Health, Inc.

Lead Sponsor

Trials

22

Recruited

66,900+

Citations

1. guardanthealth.com guardanthealth.com/products/tests-for-patients-with-early-and-advanced-stage-cancer/

Guardant Complete® for Early and Advanced Stage Cancer Guardant Reveal is a simple blood test that utilizes circulating tumor DNA (ctDNA) to detect cancer at the molecular level, offering a more precise, ctDNA- ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05059444

Observation of ResiduAl Cancer With Liquid Biopsy Evaluation 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05059444

NCT05059444 | ORACLE: Observation of ResiduAl Cancer ... Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors. Groups/Cohorts, Cohort 8: Invasive ...

4. my.clevelandclinic.org my.clevelandclinic.org/health/diseases/23180-carcinoma

Carcinoma: Types, Treatment & What it Is Carcinoma is a type of cancer that starts in tissue lining your skin, organs and internal passageways in your body. Most cancer diagnoses are carcinoma.

5. cancer.gov cancer.gov/types

A to Z List of Cancer Types - NCI Alphabetical list of all cancers, with links to disease-specific and general information about treatment, coping, screening, prevention, clinical trials, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200010S010B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Guardant360 CDx is a single-site test performed at Guardant Health, Inc. The test includes reagents, software, and procedures for testing cfDNA from whole blood.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200010S001B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Guardant360® CDx is a single-site test performed at Guardant Health, Inc. The test includes reagents, software, and procedures for testing cfDNA ...

8. guardantcomplete.com guardantcomplete.com/assets/pdf/Guardant360-CDx-Technical-Information-US.pdf

Guardant360-CDx-Technical-Information-US.pdf Safety and Effectiveness Results a. Safety Results. Data regarding the safety and efficacy of TAGRISSO therapy were presented in the original drug approval ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230009B.pdf

summary of safety and effectiveness data (ssed) The Shield test is NOT indicated for use for patients that have the following: • Personal history of colorectal cancer (CRC), adenomas, or other related ...

10. investors.guardanthealth.com investors.guardanthealth.com/press-releases/press-releases/2023/Guardant-Health-receives-FDA-approval-for-Guardant360-CDx-as-companion-diagnostic-for-Menarini-Groups-ORSERDU-for-treatment-of-patients-with-ESR1-mutations-in-ER-HER2--advanced-or-metastatic-breast-cancer/default.aspx

advanced or metastatic breast cancer Safety data is consistent with the other endocrine therapies. Most of the adverse events (AEs), including nausea and musculoskeletal pain ...