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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: Clinical Trial Operations

Phone: 8556988887

Email: mrdoraclestudy@guardanthealth.com

LOCATION