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

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
• Rectal Adenocarcinoma

ELIGIBILITY

Inclusion Criteria:
* 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

- * 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 Landmark blood sample
Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:
Primary Study Cohorts
* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),

- * Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III),

- * Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:
Cohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive/HER2-negative invasive breast carcinoma
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: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,

- * Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus 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),

- * Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen
Exclusion Criteria:
* 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, 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)

- * 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: [email protected]

LOCATION