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Blood test to detect returning cancer after treatment of early-stage solid tumors

Tests a tumor DNA blood test for detecting returning cancer after treatment.

Key facts

Who runs it
Guardant Health, Inc.
Where
Besançon, Levallois-Perret, Marseille, Neuilly, and Paris, FranceSee the 5 sitesAlso in 4 other countries, 52 sites
Trial code
Registry title
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Status
Recruiting
People taking part
2,285 people, planned
Started
7 Sept 2021
Expected to end
Aug 2030
Type of study
Observational, 12 groups
Treatments tested
  • Guardant Reveal
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults treated with the aim of removing early-stage solid tumors. A blood test for tumor DNA is checked against recurrence of the cancer.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Several cancer types in early stages are accepted, for example muscle invasive bladder cancer (stage II-III), non-small cell lung cancer (stage IB-III) and colon cancer (stage II-III). The cancer must be confirmed by tissue examination.
Earlier treatment
First treatment was given to remove all of the disease. Participants have at least one blood sample taken 3-12 weeks after surgery, chemotherapy or radiation.
Biomarker or test result
Breast cancer cohorts need known hormone receptor and HER2 status. No other test result is asked for.

Main reasons for not taking part

  • History of an organ or tissue transplant from another person
  • Cancer that is mostly neuroendocrine
  • Another cancer diagnosed within 3 years before joining, with some exceptions
  • Known distant metastasis at enrolment, with exceptions for limited stage IV melanoma or renal cell carcinoma

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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 3 years as outlined in the study protocol and informed consent AND
  • Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen
  • 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: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus),
  • Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),
  • Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),
  • Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)
  • Cohort 12: Colorectal adenocarcinoma Cohort 12A: 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 OR Cohort 12B: Colon adenocarcinoma (stage II-III)

Who cannot take part

  • 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 (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), 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 in France

Also in 4 other countries, 52 sites

  • CHU BesançonBesançon, FranceContact: Mathilde DoneyTaking people
  • Hôpital Franco-BritanniqueLevallois-Perret, FranceContact: Hajar EddahbiTaking people
  • Institut Paoli-CalmettesMarseille, FranceContact: Ines AyadTaking people
  • Ambroise Paré-HartmannNeuilly, FranceContact: Rayene SoualhiTaking people
  • APHP Tenon Hospital - SorbonneParis, FranceContact: Hakima ManseurTaking people

About the trial

What the trial wants to find out

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.

The 12 groups in the trial

  • Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)

    Treatment: Guardant Reveal

  • Cohort 2: Non-small cell lung cancer (stage IB-III)

    Cohort 2A: Resectable Cohort 2B: Unresectable

    Treatment: Guardant Reveal

  • 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)

    Treatment: Guardant Reveal

  • Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma

    Treatment: Guardant Reveal

  • Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)

    Treatment: Guardant Reveal

  • Cohort 6: Gastric adenocarcinoma (stage II-III)

    Treatment: Guardant Reveal

  • Cohort 7: Pancreatic adenocarcinoma

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

    Treatment: Guardant Reveal

  • Cohort 8: Invasive squamous cell carcinoma of the head and neck

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

    Treatment: Guardant Reveal

  • Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma

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

    Treatment: Guardant Reveal

  • Cohort 10: Endometrial carcinoma

    Defined as 2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype

    Treatment: Guardant Reveal

  • Cohort 11: High-risk renal cell carcinoma

    Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent).

    Treatment: Guardant Reveal

  • Cohort 12: Colorectal adenocarcinoma

    12A Rectal Adenocarcinoma: 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 12B Colon Adenocarcinoma: stage II-III

    Treatment: Guardant Reveal

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Plain-language title
Blood test to detect returning cancer after treatment of early-stage solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 September 2026