[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-pelvis-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-pelvis-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100443825","oracle-observation-of-residual-cancer-with-liquid-biopsy-evaluation-100443825",false,"NCT05059444","ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation","ORACLE","Inclusion Criteria:\n\n* Age \\> 18 years old AND\n* Initial treatment is given with curative\u002Fradical intent AND\n* Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND\n* Provided written informed consent to participate in the study AND\n* Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND\n* 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\n* Have at least one Landmark blood sample\n\nHave a histologically confirmed Index Cancer that qualifies for inclusion, defined as:\n\nPrimary Study Cohorts\n\n* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),\n* Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):\n\nCohort 2A: Resectable OR Cohort 2B: Unresectable,\n\n* 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:\n\nCohort 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\u002FHER2-negative invasive breast carcinoma,\n\n* Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,\n* Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),\n* Cohort 6: Gastric adenocarcinoma (stage II-III),\n* Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,\n* 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),\n* Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),\n* Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),\n* 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)\n\nExploratory Cohort\n\n* 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\n\nExclusion Criteria:\n\n* History of allogeneic organ or tissue transplant\n* Index cancer has predominantly neuroendocrine histology\n* 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\u002Fmultifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment\n* Known distant metastasis at time of enrollment (with the exception of participants with limited\u002Fresectable stage IV cutaneous melanoma or RCC)","ALL","18 Years",{"count":19,"type":20},2020,"ESTIMATED","OBSERVATIONAL","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.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"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","RECRUITING","2025-08-18",{"date":43,"type":44},"2025-08-22","ACTUAL",{"date":46,"type":44},"2021-09-07",{"date":48,"type":20},"2029-08",{"name":50,"class":51},"Guardant Health, Inc.","INDUSTRY",57]