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Observing cancer recurrence using a blood test

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Guardant Health, Inc. · NCT05059444

This study is testing a new blood test to see if it can help find out if cancer comes back in people who have been treated for early-stage solid tumors.

Quick facts

Study typeObservational
Enrollment2020 (estimated)
Ages18 Years and up
SexAll
SponsorGuardant Health, Inc. (industry)
Drugs / interventionschemotherapy, immunotherapy
Locations57 sites (Birmingham, Alabama and 56 other locations)
Trial IDNCT05059444 on ClinicalTrials.gov

What this trial studies

The ORACLE study aims to evaluate a novel ctDNA assay developed by Guardant Health for its ability to detect cancer recurrence in patients who have undergone treatment for early-stage solid tumors. Participants will provide blood samples at enrollment and during regular follow-up visits over a period of up to five years. The study will link ctDNA test results to clinical outcomes to establish the assay's clinical validity and explore its potential value in a cost-conscious healthcare environment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have undergone initial treatment for early-stage solid tumors and are planning regular follow-up for cancer recurrence.

Not a fit: Patients who are not undergoing regular follow-up monitoring or those with advanced-stage cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a reliable method for early detection of cancer recurrence, potentially improving patient outcomes.

How similar studies have performed: Other studies utilizing ctDNA assays for cancer recurrence detection have shown promise, indicating that this approach is gaining traction in the field.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Birmingham, Alabama and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Bladder Carcinoma, Ureter Carcinoma, Renal Pelvis Carcinoma, Non-small Cell Lung Cancer, Invasive Breast Carcinoma, Cutaneous Melanoma, Esophageal Carcinoma, Gastroesophageal Junction Carcinoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.