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Brief Title: ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

INTRODUCTION

  • Org Study ID: 02-MX-003
  • Secondary ID: N/A
  • NTC ID: NCT05059444
  • Sponsor: Guardant Health, Inc.

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.

  • Overall Status
    Recruiting
  • Start Date
    September 7, 2021
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Distant Recurrence Free Interval (D-RFi)

Primary Outcome 1 - Timeframe: 6 years

CONDITION

  • 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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Study Director

Role: Study Director

Affiliation: Guardant Health, Inc.

Overall Contact

Name: Study Director

Phone: 8556988887

Email: mrdoraclestudy@guardanthealth.com

LOCATION

Facility Status Contact
Facility: Redwood City
Redwood City, California 94063
United States
Status: Recruiting Contact: Contact
Clinical Trial Operations