[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07390643":3,"trial-entities:NCT07390643":114,"trial-summary:NCT07390643":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":56,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":86,"locations":89,"central_contacts":107,"overall_officials":110,"references":112,"see_also_links":113},"NCT07390643","25-467","The DISCOVER Study","Determining ImpactS of Multi-Cancer Early detectiOn Tests oVER Time in Symptomatic Patients: The DISCOVER Study","NOT_YET_RECRUITING","2028-01-31","2026-01","2026-02-05","2026-07","Dana-Farber Cancer Institute","OTHER",false,"The purpose of this research study is to evaluate the possible benefits of screening with an investigational, but commercially available blood test designed to detect many types of cancer.\n\nThe name of the screening blood test being studied is:\n\n-GRAIL Galleri MCED test","The purpose of this pilot research study is to evaluate the possible benefits of screening with an investigational, but commercially available blood test designed to detect many types of cancer. \"Investigational\" means that this test is being studied and is not approved or cleared by the Food and Drug Administration (FDA).\n\nThe multi-cancer early detection test looks for small pieces of genetic material, called DNA (deoxyribonucleic acid), in the blood that may indicate the presence of cancer, and the test may also be able to suggest what type of cancer is present.\n\nThe research study procedures include screening for eligibility, in-clinic visit, blood tests, and questionnaires.\n\nIt is expected that about 110 people will take part in this research study.",[19,20],"Cancer","Cancer Diagnosis",[19,20],"INTERVENTIONAL","SCREENING",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","GRAIL Galleri MCED test","A multi-cancer early detection (MCED) blood test.",[35],"Galleri MCED Test",[37,41,44,47,50,53],{"measure":38,"description":39,"timeFrame":40},"Multi-cancer Early Detection (MCED) Positive Cancer Type","MCED positive cancer type is defined as the type of cancer detected by the MCED test. Cancer type will be defined and recorded using ICD-O-3 codes for primary anatomic site (topography) and histology (morphology).","MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.",{"measure":42,"description":43,"timeFrame":40},"Multi-cancer Early Detection (MCED) Positive Cancer Incidence","MCED positive cancer incidence is defined as the number of cancers detected by the MCED test.",{"measure":45,"description":46,"timeFrame":40},"Multi-cancer Early Detection (MCED) Positive Cancer Stage","MCED positive cancer stage is defined as the stage of cancer detected by the MCED test.",{"measure":48,"description":49,"timeFrame":40},"Multi-cancer Early Detection (MCED) Undetected Cancer Type","MCED undetected cancer type is defined as the cancer type detected by standard diagnostic methods that was not identified by the MCED test. Cancer type will be recorded using ICD-O-3 codes for both the primary anatomic site (topography) and histology (morphology).",{"measure":51,"description":52,"timeFrame":40},"Multi-cancer Early Detection (MCED) Undetected Cancer Incidence","MCED undetected cancer incidence is defined as the number of cancers detected by standard diagnostic methods that was not identified by the MCED test.",{"measure":54,"description":55,"timeFrame":40},"Multi-cancer Early Detection (MCED) Undetected Cancer Stage","MCED undetected cancer stage is defined as the stage of cancer detected by standard diagnostic methods that was not identified by the MCED test. Hodgkin lymphoma (HL) is typically staged using the Ann Arbor system; non-Hodgkin lymphoma (NHL) is staged according to the Lugano classification; multiple myeloma (MM) is staged using the International Staging System (ISS); and chronic lymphocytic leukemia (CLL) is staged according to the Rai staging system.",[57,61,64,67,70],{"measure":58,"description":59,"timeFrame":60},"Positive Predictive Value (PPV) of Multi-cancer Early Detection (MCED)","PPV of the MCED test will be calculated as the proportion of participants diagnosed with cancer among all participants who had positive MCED test results.","12 months",{"measure":62,"description":63,"timeFrame":40},"Number of Additional Tests","Number of additional tests is defined as total number of diagnostic tests performed to achieve final diagnostic resolution after the initial MCED test.",{"measure":65,"description":66,"timeFrame":40},"Types of Additional Tests","Types of additional tests are defined as the specific types of diagnostic tests performed to reach final diagnostic resolution after the initial MCED test.",{"measure":68,"description":69,"timeFrame":40},"Tissue of Origin Correct Prediction Rate","Tissue of origin correct prediction rate is defined as the proportion of participants in whom the tissue of origin predicted by the GRAIL Galleri® MCED test matches the confirmed cancer site, based on cancer status assessments.",{"measure":71,"description":72,"timeFrame":73},"Qualitative Provider Assessment of MCED Test Utility","At the end of the study, participating providers will be surveyed to assess their attitudes, perceptions, and experiences regarding the utility and integration of MCED tests in clinical practice. The assessment includes multiple-choice questions, and open-ended questions.","24 months","ALL","22 Years",null,true,{"inclusion":79,"exclusion":82,"raw_text":85},[80,81],"Be at least 22 years old","Have signs and symptoms suggestive of cancer and\u002For have imaging related to signs and symptoms of cancer being evaluated in the Cancer Diagnostic Service clinic",[83,84],"Individuals diagnosed with invasive malignancy within 3 years of enrollment","Individuals with active cancer requiring active therapeutic intervention at the time of participation (hormone therapy for breast\u002Fprostate cancer is considered acceptable and will not preclude participation)","Inclusion Criteria:\n\n* Be at least 22 years old\n* Have signs and symptoms suggestive of cancer and\u002For have imaging related to signs and symptoms of cancer being evaluated in the Cancer Diagnostic Service clinic\n\nExclusion Criteria:\n\n* Individuals diagnosed with invasive malignancy within 3 years of enrollment\n* Individuals with active cancer requiring active therapeutic intervention at the time of participation (hormone therapy for breast\u002Fprostate cancer is considered acceptable and will not preclude participation)",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":13,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":104},"Boston","Massachusetts","02215","United States",[96,101],{"name":97,"role":98,"phone":99,"email":100},"Elizabeth O'Donnell, MD","CONTACT","857-215-2361","elizabeth_odonnell@dfci.harvard.edu",{"name":102,"role":103},"Elizabeth ODonnell, MD","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},42.35843,-71.05977,[108],{"name":97,"role":98,"phone":99,"email":109},"Elizabeth_odonnell@dfci.harvard.edu",[111],{"name":97,"affiliation":13,"role":103},[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Malignant Neoplasm",[],{"nct_id":4,"found":77,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study, meaning participants will receive a specific intervention (the GRAIL Galleri MCED test). It plans to enroll about 100 people.","completed","The DISCOVER Study: Evaluating the GRAIL Galleri MCED Test for Cancer Detection","The DISCOVER Study is evaluating a blood test called the GRAIL Galleri MCED test. This test looks for signs of many different types of cancer early. You might be able to join if you are at least 22 years old and have symptoms or imaging results that suggest cancer. The study aims to see how well this test can find cancer, what type of cancer it detects, and at what stage, all within 12 months of testing. This is a pilot study, meaning it's an initial evaluation, and it plans to include about 100 people.","The study will follow up on diagnostic resolution and cancer type determination within 12 months after the MCED test.",95,"You would have a screening visit to check eligibility, an in-clinic visit, blood tests, and fill out questionnaires.","Not stated in the trial record.",[32],"v2"]