Overview

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

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