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ORACLE: Observing Residual Cancer with Guardant Reveal

The ORACLE study is looking at how well a test called Guardant Reveal can find if cancer has come back in people who have been treated for early-stage solid tumors. This includes bladder, ureter, renal pelvis, non-small cell lung, and invasive breast cancers. The study wants to see if Guardant Reveal, which is a liquid biopsy (a test using a blood sample), can accurately detect cancer recurrence. Researchers will follow participants for 3 years to see if the test results match whether their cancer returns. You could join if you are over 18, have received initial treatment for your cancer with the goal of a cure, and are planning to have regular follow-up care.

Study design
This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to enroll 2020 participants.
What's involved
You would need to agree to share your de-identified clinical data and have regular follow-up and monitoring for cancer recurrence as part of your standard care.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 years to measure the Distant Recurrence Free Interval (D-RFi).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05059444

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Recruiting
Not specifiedAges 18+Observational
Guardant Health, Inc.
~2,020 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:Guardant Reveal

At a glance

Recruiting sites
51 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Distant Recurrence Free Interval (D-RFi)
Measured over 3 years

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

Explore related trials

Bladder CarcinomaBreast CarcinomaEndometrial CarcinomaEsophageal CarcinomaFallopian Tube CarcinomaGastric AdenocarcinomaGastroesophageal Junction CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMelanomaOvarian CarcinomaPancreatic AdenocarcinomaRectal AdenocarcinomaRenal Cell CarcinomaRenal Pelvis CarcinomaUreter Carcinoma

Where it's being run

57 sites across 24 states
Spain13
France5
California4
Texas4
Ohio3
Pennsylvania3
Germany3
Italy3

Study leadership

  • Study Director · STUDY_DIRECTOR · Guardant Health, Inc.

Who to contact

Clinical Trial Operations
[email protected]
8556988887
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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 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)
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

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)

What this trial measures

  • Distant Recurrence Free Interval (D-RFi)3 years

    The primary endpoint, distant recurrence-free interval (D-RFi), will be evaluated for each of the primary study cohorts. D-RFi is defined as the time from the end of primary treatment until the time of diagnosis of a distant recurrence of the Index Cancer. Subjects without a distant recurrence will be censored at the time of last follow-up of their Index Cancer.