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

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT05059444

Sponsor: Guardant Health, Inc.

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

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

View trial on ClinicalTrials.gov