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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)

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ClinicalTrials.gov Identifier: NCT05059444
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Guardant Health, Inc.

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment
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 Diagnostic Test: Guardant Reveal

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : February 2028
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III) Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 2: Non-small cell lung cancer (stage II-III) Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 3: Invasive breast carcinoma with all of the following:
  • Clinical stage T1-4/N0-3/M0 at presentation AND
  • Completed preoperative systemic chemotherapy-containing regimen AND
  • Underwent definitive surgical resection of the primary tumor AND
  • Has pathological evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes AND
  • Hormone receptor and HER2 status are known
 Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III) Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 6: Gastric adenocarcinoma (stage II-III) Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 7: Surgically resected pancreatic adenocarcinoma Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
Cohort 8: Invasive squamous cell carcinoma of the head and neck
Includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers.
 Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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).
 Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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).
 Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
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.
 Diagnostic Test: Guardant Reveal
Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.


Outcome Measures
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Primary Outcome Measures :
  1. Distant Recurrence Free Interval (D-RFi) [ Time Frame: 6 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.


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: 6 years ]
    Sensitivity defined as the proportion of participants who develop distant recurrence who have ctDNA detected at or before the time of clinical detection of recurrence.

  2. Positive Predictive Value [ Time Frame: 6 years ]
    Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected at the landmark or any surveillance timepoint who recur (either distally or locally).

  3. Lead Time [ Time Frame: 6 years ]
    Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.


Other Outcome Measures:
  1. Recurrence-free interval (RFi) [ Time Frame: 6 years ]
    Recurrence-free interval (RFi) defined as the time from the end of primary treatment until the appearance/occurrence of any recurrence (distant, regional, and/or local) of the Index Cancer. Subjects without recurrence will be censored at the time of last follow-up of their Index Cancer.

  2. Negative predictive value (NPV) [ Time Frame: 6 years ]
    Negative predictive value (NPV) defined as the proportion of participants who have ctDNA not detected who have no evidence of recurrence.

  3. Association with resolution of indeterminate findings [ Time Frame: 6 years ]
    1. The proportion of individuals whose indeterminate finding is ultimately confirmed to be disease recurrence who have ctDNA detected at the initial time the indeterminate finding is identified and
    2. The proportion of ctDNA not detected participants whose indeterminate findings is ultimately confirmed to be benign.

  4. Sensitivity for local recurrence [ Time Frame: 6 years ]
    Sensitivity for local recurrence defined as the proportion of participants who have localized recurrence (e.g., in the absence of distant metastasis) who have ctDNA detected at or before the time of clinical detection of a localized recurrence; using landmark and serial timepoints.

  5. Index Cancer-Specific Survival (ICSS) [ Time Frame: 6 years ]
    Index Cancer-Specific Survival (ICSS) defined as the time from the date of diagnosis until the date of death from the subject's Index Cancer. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.

  6. Overall Survival (OS) [ Time Frame: 6 years ]
    Overall Survival (OS) defined as the time from the date of diagnosis until the date of death from any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.

  7. Rate of ctDNA clearance with adjuvant chemotherapy [ Time Frame: 6 years ]
    Rate of ctDNA clearance with adjuvant chemotherapy defined as the proportion of patients who have ctDNA detected at the pre-enrollment timepoint whose ctDNA becomes undetectable at the Landmark timepoint.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The primary study population will include participants with invasive bladder, ureteral, or renal pelvis carcinoma, NSCLC, or breast cancer with residual invasive disease following neoadjuvant chemotherapy as per inclusion/exclusion criteria defined. Exploratory cohorts include participants with cutaneous melanoma, esophageal carcinoma, gastroesophageal junction carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, squamous cell carcinoma of the head and neck, epithelial ovarian/Fallopian tube carcinoma, endometrial cancer, and renal cell carcinoma (RCC), as per inclusion/exclusion criteria. Approximately 1,000 total patients will be enrolled into the study.
Criteria

Inclusion Criteria:

  • Age > 18 years old AND
  • Were treated with curative 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 blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer
  • Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts

  • Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
  • Cohort 2: Non-small cell lung cancer (stage II-III),
  • Cohort 3: Invasive breast carcinoma with all of the following:

Clinical stage T1-4/N0-3/M0 at presentation AND Completed preoperative systemic chemotherapy-containing regimen AND Underwent definitive surgical resection of the primary tumor AND Has pathological evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes AND Hormone receptor and HER2 status are known

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: Surgically resected pancreatic adenocarcinoma,
  • Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland 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)

Exclusion Criteria:

  • History of allogeneic organ or tissue transplant
  • Index cancer has neuroendocrine histology
  • History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score < 6) with PSA in the normal range, and stage I papillary thyroid carcinoma.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059444


Contacts
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Contact: Clinical Trial Operations 8556988887 mrdoraclestudy@guardanthealth.com

Locations
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United States, California
Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Clinical Trial Operations         
Sponsors and Collaborators
Guardant Health, Inc.
Investigators
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Study Director: Study Director Guardant Health, Inc.
More Information
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Responsible Party: Guardant Health, Inc.
ClinicalTrials.gov Identifier: NCT05059444    
Other Study ID Numbers: 02-MX-003
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Endometrial Neoplasms
Carcinoma, Ovarian Epithelial
Esophageal Neoplasms
Urinary Bladder Neoplasms
Neoplasm, Residual
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
Carcinoma, Squamous Cell
 Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urologic Diseases
Male Urogenital Diseases
Breast Diseases
Head and Neck Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Genital Diseases
Ovarian Neoplasms