[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guardant Health, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100638432","decision-counseling-and-follow-up-for-shield-patients-100638432",false,"NCT07620535","Decision Counseling and Follow-up for Shield+ Patients","Decision Counseling and Follow-up (DCaF) for Shield+ Patients","DCaF","Inclusion Criteria:\n\n* Participant is 45-75 years old at the time of ShieldTM test order.\n* Participant has a valid Shield(+) test result.\n* Participant is willing and able to complete the informed consent process\n* Participant is able to complete the informed consent process and decision counseling session in English\n\nExclusion Criteria:\n\n* Participant is already enrolled in another Guardant Health, Inc. clinical study or has received a positive MCD result for a cancer type other than CRC.",true,"ALL","45 Years","75 Years",{"count":22,"type":23},350,"ESTIMATED","OBSERVATIONAL","Prospective, observational, minimal-risk study evaluating decision-making, decisional conflict, intention to undergo complete diagnostic evaluation (CDE), and colonoscopy completion after a positive Shield TM blood-based colorectal cancer screening test result.",[27],"Colo-rectal Cancer",[27,29],"Screening","NOT_YET_RECRUITING","2026-05-27",{"date":33,"type":34},"2026-06-02","ACTUAL",{"date":36,"type":23},"2026-06",{"date":38,"type":23},"2028-06",{"name":40,"class":41},"Guardant Health, Inc.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100583725","shield-post-approval-study-protocol-100583725","NCT06880055","Shield Post-Approval Study Protocol","SOLAR","Inclusion Criteria:\n\n1. Subjects aged 45-81 years at time of consent\n2. Intending to undergo a standard of care Shield test\n3. Considered by a physician or healthcare provider as being of 'average risk' for CRC; 'Average-risk' individuals in the context of CRC screening are defined as those who do not have symptoms of CRC and do not have increased risk factors for the disease (i.e., prior diagnosis of CRC, adenomatous polyps, or inflammatory bowel disease; family history of CRC or known hereditary predisposition to CRC).\n4. Subject agrees to comply with study procedures and associated standard of care assessments.\n\nExclusion Criteria:\n\n1. Undergoing colonoscopy for investigation of symptoms\n2. Personal history of colorectal cancer (CRC), adenomas, or other related cancers\n3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age\n4. Positive result on another colorectal cancer screening method within the last six months, or:\n\n   * 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT)\n   * 36 months for FIT-DNA test\n5. Personal history of any of the following high-risk conditions for colorectal cancer:\n\n   * Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease\n   * Familial adenomatous polyposis (FAP)\n   * Other hereditary cancer syndromes including but not limited to:\n\n     * Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or \"Lynch Syndrome\", Peutz- Jeghers Syndrome, MUTYH Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis\n6. Positive Shield test result within the previous 3 years\n7. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)\n8. Known diagnosis of inflammatory bowel disease\n9. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)\n10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent\n11. Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study\n12. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy","81 Years",{"count":52,"type":23},3375,"The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.",[27],[29,56],"Shield","RECRUITING","2026-03-18",{"date":60,"type":34},"2026-03-19",{"date":62,"type":34},"2025-07-14",{"date":64,"type":23},"2030-12-01",{"name":40,"class":41},56,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":42},"100511126","sibyl-observation-of-therapy-response-with-liquid-biopsy-evaluation-100511126","NCT05935384","SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation","Inclusion Criteria\n\nEach participant must satisfy all the following criteria to be enrolled in the study:\n\n1. Age ≥18 years old\n2. Are treated with systemic therapy and\u002For oral SOC regimen at the site of enrollment during entirety of study\n3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy\n4. Able to understand, and capable of providing written consent to participate in the study\n5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent\n6. Are willing to provide blood samples at enrollment and at subsequent clinical visits\n7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:\n\n   * Cohort 1: Unresectable Stage III\u002FIV NSCLC (\\~125)\n   * Cohort 2: Stage IV Colorectal (\\~125)\n   * Cohort 3: Unresectable Stage III\u002FIV Breast - HR+ HER2- (\\~55)\n   * Cohort 4: Unresectable Stage III\u002FIV Breast - HR- HER2+ (\\~55)\n   * Cohort 5: Unresectable Stage III\u002FIV Breast - HR+ HER2+ (\\~55)\n   * Cohort 6: Unresectable Stage III\u002FIV Breast - Triple Negative (\\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.\n\nExclusion Criteria\n\nAny potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:\n\n1. History of prior solid malignancy or hematological malignancy within five years of enrollment\n2. Life expectancy ≤12 weeks\n3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen\n4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting\u002Fpredicting clinical response\u002Fprogression","18 Years",{"count":75,"type":23},470,"The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.",[78,79,80],"Non-small Cell Lung Cancer","Colorectal Cancer","Breast Cancer","2025-08-18",{"date":83,"type":34},"2025-08-22",{"date":85,"type":34},"2023-10-25",{"date":87,"type":23},"2030-12-30",{"name":40,"class":41},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100443825","oracle-observation-of-residual-cancer-with-liquid-biopsy-evaluation-100443825","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)",{"count":97,"type":23},2020,"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.",[100,101,102,78,103,104,105,106,107,108,109,110,111,112,113,114],"Bladder Carcinoma","Ureter Carcinoma","Renal Pelvis Carcinoma","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",{"date":83,"type":34},{"date":117,"type":34},"2021-09-07",{"date":119,"type":23},"2029-08",{"name":40,"class":41},57,""]