oracle: observation of residual cancer with liquid biopsy evaluation

Conditions: 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

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.


Eligibility criteria:
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