ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Non-small Cell Lung Cancer Clinical Trial

— ORACLE  

Official title:

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05059444
• Other study ID #: 02-MX-003
• Status: Recruiting
• Start date: September 7, 2021
• Est. completion date: February 2028

Study information

• Verified date: September 2022
• Source: Guardant Health, Inc.
• Contact: Clinical Trial Operations
• Phone: 8556988887
• Email: mrdoraclestudy[@]guardanthealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Bladder Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Ovarian Epithelial
• Cutaneous Melanoma
• Endometrial Carcinoma
• Endometrial Neoplasms
• Epithelial Ovarian Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms
• Fallopian Tube Carcinoma
• Gastric Adenocarcinoma
• Gastroesophageal Junction Carcinoma
• Invasive Breast Carcinoma
• Neoplasm, Residual
• Non-small Cell Lung Cancer
• Pancreatic Adenocarcinoma
• Renal Cell Carcinoma
• Renal Pelvis Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck
• Ureter Carcinoma
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Redwood City	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Guardant Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 years
Other	Negative predictive value (NPV)	Negative predictive value (NPV) defined as the proportion of participants who have ctDNA not detected who have no evidence of recurrence.	6 years
Other	Association with resolution of indeterminate findings	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; The proportion of ctDNA not detected participants whose indeterminate findings is ultimately confirmed to be benign.	6 years
Other	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.	6 years
Other	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.	6 years
Other	Overall Survival (OS)	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.	6 years
Other	Rate of ctDNA clearance with adjuvant chemotherapy	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.	6 years
Primary	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.	6 years
Secondary	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.	6 years
Secondary	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).	6 years
Secondary	Lead Time	Lead time defined as the interval between ctDNA detection and clinical detection of recurrence.	6 years