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ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

ConditionsBladder CarcinomaUreter CarcinomaRenal Pelvis CarcinomaNon-small Cell Lung CancerInvasive Breast CarcinomaCutaneous MelanomaEsophageal CarcinomaGastroesophageal Junction CarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaSquamous Cell Carcinoma of the Head and NeckEpithelial Ovarian CarcinomaFallopian Tube CarcinomaEndometrial CarcinomaRenal Cell CarcinomaRectal AdenocarcinomaColon Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuardant Health, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

The primary study population will include participants with invasive bladder/upper urinary tract carcinoma, NSCLC, breast cancer, 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, renal cell carcinoma (RCC), and colorectal cancer as per inclusion/exclusion criteria below. Inclusion criteria were selected to enroll participants who are predicted to have \>15-20% risk of recurrence within 3 years in order to sufficiently power the study for recurrence events.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Guardant Reveal

    Diagnostic test

    Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.

Treatment groups

2,285 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)1 intervention
Group B: Cohort 2: Non-small cell lung cancer (stage IB-III)1 intervention
Group C: Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status1 intervention
Group D: Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma1 intervention
Group E: Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)1 intervention
Group F: Cohort 6: Gastric adenocarcinoma (stage II-III)1 intervention
Group G: Cohort 7: Pancreatic adenocarcinoma1 intervention
Group H: Cohort 8: Invasive squamous cell carcinoma of the head and neck1 intervention
Group I: Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma1 intervention
Group J: Cohort 10: Endometrial carcinoma1 intervention
Group K: Cohort 11: High-risk renal cell carcinoma1 intervention
Group L: Cohort 12: Colorectal adenocarcinoma1 intervention

Trial outcomes

Primary outcomes

1

Distant Recurrence Free Interval (D-RFi)

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.

Time frame
3 years

Secondary outcomes

1

Sensitivity

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.

Time frame
3 years
2

Positive Predictive Value

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).

Time frame
3 years
3

Lead Time

Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.

Time frame
3 years
4

Specificity

Specificity defined as the proportion of participants who are recurrence-free who have ctDNA not detected.

Time frame
3 years

Other outcomes

1

Recurrence-free interval (RFi)

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.

Time frame
3 years
2

Association with resolution of indeterminate findings

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.

Time frame
3 years
3

Sensitivity for local recurrence

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.

Time frame
3 years
4

Index Cancer-Specific Survival (ICSS)

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.

Time frame
3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guardant Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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