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: 3 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
• Colon 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 3 years as outlined in the study protocol and informed consent AND

- * Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen

- * 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 2A: Resectable OR Cohort 2B: Unresectable,
* 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,
* 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: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus),

- * Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),

- * Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),

- * Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)

- * Cohort 12: Colorectal adenocarcinoma Cohort 12A: 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 OR Cohort 12B: Colon adenocarcinoma (stage II-III)
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 (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), 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)

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