[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05833360":3,"trial-entities:NCT05833360":114,"trial-summary:NCT05833360":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":16,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":16,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":66,"locations":69,"central_contacts":100,"overall_officials":102,"references":105,"see_also_links":110},"NCT05833360","CP-23001","Prospective Study of oncRNA Stratification of Cancer by Size and Stage","RECRUITING","2030-07-14","2025-03","2025-03-18","2023-07-14","Exai Bio Inc.","INDUSTRY",false,"Cancer strikes about one in three women and one in two men in the U.S. and more than 600,000 die from it each year. The best chance to reduce these numbers and save lives is through early detection and intervention.\n\nThe investigators are developing a blood test to detect cancer from a simple blood draw also referred to as a liquid biopsy. This test is based on orphan non-coding RNAs (oncRNAs) that are abundant in the blood of patients with cancer and largely absent in people without cancer. Using artificial intelligence (AI) and machine learning (ML) investigators are able to interpret the thousands of oncRNAs found in the blood of patients with cancer by identifying unique, cancer-specific patterns. oncRNA patterns can be used to detect several types of cancer and detect cancer at the earliest stages.\n\nThis is a prospective, observational study to collect blood samples and medical information from participants with and without cancer to represent the population in the USA. The investigators have designed the study to include participants without cancer, participants with conditions that are a predisposition for cancer, participants with pre-malignant lesions, and participants with cancer. Patients with a wide variety of cancers are going to be included i.e. bladder, breast, colorectal, esophageal, gastric, kidney, liver, lung, ovarian, pancreatic, prostate, and uterine cancer.\n\nEach participant will be asked to donate a small blood sample and to share their medical information. The participant's medical information will be updated during the course of the study. The blood will be tested for oncRNA. The objective is to create a blood repository and associated medical database to develop a blood test for cancer, for different cancer types. The study is designed to be inclusive and represent the population in America.\n\nIf this study is successful, the results will enable a world where cancer can be detected early with a simple blood test and diagnosed accurately, with better chances of cure. The investigators believe this study has the potential to transform cancer detection in America.",null,[18],"Cancer",[20,21,22,23],"cancer","liquid biopsy","early detection","diagnostics","OBSERVATIONAL",[],{"count":27,"type":28},2400,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Exai oncRNA blood test","A phlebotomist will collect approximately 40 ml (about 2-3 tablespoons) of blood from the subjects after consent. The Exai oncRNA blood test will be run on the blood samples.",[35,36,37,38],"Cancer Patients Cohort","Cancer Predisposition Cohort","Control Cohort","Pre-Malignant Condition Cohort",[40,44],{"measure":41,"description":42,"timeFrame":43},"Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology","Analyze small noncoding (snc)RNA profiles differentially expressed in specimens obtained from case and control subjects to identify candidate sncRNA biomarkers for use in deriving and optimizing oncRNA diagnostic models for multiple cancer applications, including screening, early diagnosis, minimal residual disease and monitoring for tumor recurrence","Seven years",{"measure":45,"description":46,"timeFrame":43},"Optimize oncRNA test clinical performance","Assess small noncoding (snc)RNA profiles potentially associated with demographic parameters, medication use, comorbid conditions, and\u002For cancer-predisposing conditions which might overlap with candidate cancer biomarkers to optimize oncRNA model clinical specificity performance, i.e., minimize false positives.",[],"ALL","18 Years",true,{"inclusion":52,"exclusion":56,"raw_text":65},[53,54,55],"Age ≥18 years","Able and willing to provide informed consent","Able and willing to have 35-40 mL of whole blood drawn",[57,58,59,60,61,62,63,64],"Age \\\u003C18 years","Prior history of cancer, except for non-melanoma skin cancer","Prior history of receipt of any blood products within 30 days of enrollment","Receipt of any cancer therapy, e.g., surgical, radiation, or medical including neoadjuvant treatment, prior to study enrollment","Prior history of receipt of any non-cancer system immune modulation therapy within the last 60 days (ex: monoclonal antibodies)","Prior history of organ transplantation","Current or prior pregnancy within the last 12 months","Unable or unwilling to provide informed consent","Inclusion Criteria:\n\n* Age ≥18 years\n* Able and willing to provide informed consent\n* Able and willing to have 35-40 mL of whole blood drawn\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Prior history of cancer, except for non-melanoma skin cancer\n* Prior history of receipt of any blood products within 30 days of enrollment\n* Receipt of any cancer therapy, e.g., surgical, radiation, or medical including neoadjuvant treatment, prior to study enrollment\n* Prior history of receipt of any non-cancer system immune modulation therapy within the last 60 days (ex: monoclonal antibodies)\n* Prior history of organ transplantation\n* Current or prior pregnancy within the last 12 months\n* Unable or unwilling to provide informed consent",[67,68],"ADULT","OLDER_ADULT",[70,84],{"facility":12,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Palo Alto","California","94303","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Clinical Operations Team","CONTACT","650-204-0423","clinical-ops@exai.bio",{"lat":82,"lon":83},37.44188,-122.14302,{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":74,"contacts":89,"geoPoint":97},"Renown Health","Reno","Nevada","89502",[90,94],{"name":91,"role":78,"phone":92,"email":93},"Renown Office of Clinical Research","775-982-3646","renown-crd@renown.org",{"name":95,"role":96},"Lee S Schwartzberg, MD","PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},39.52963,-119.8138,[101],{"name":77,"role":78,"phone":79,"email":80},[103],{"name":104,"affiliation":12,"role":96},"Lee Schwartzberg, MD",[106],{"pmid":107,"type":108,"citation":109},"30397354","BACKGROUND","Fish L, Zhang S, Yu JX, Culbertson B, Zhou AY, Goga A, Goodarzi H. Cancer cells exploit an orphan RNA to drive metastatic progression. Nat Med. 2018 Nov;24(11):1743-1751. doi: 10.1038\u002Fs41591-018-0230-4. Epub 2018 Nov 5.",[111],{"label":112,"url":113},"circulating oncRNAs present a novel avenue for cancer fingerprinting using liquid biopsies","https:\u002F\u002Fwww.nature.com\u002Farticles\u002Fs41591-018-0230-4",{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Malignant Neoplasm",[],{"nct_id":4,"found":50,"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 observational study aiming to enroll 2400 participants. It is not specified if it is randomized or blinded.","completed","Observational Study of Exai oncRNA Blood Test for Cancer Detection","This study is looking at a new blood test called the Exai oncRNA blood test to find cancer early. Researchers believe that special small noncoding RNAs (oncRNAs) are found in the blood of people with cancer but not in healthy people. By using artificial intelligence (AI) and machine learning (ML), they hope to find unique cancer patterns in these oncRNAs. The goal is to make this blood test better at finding cancer and to improve how well it works. You can join if you are 18 or older, are willing to give informed consent, and can have about 2-3 tablespoons of blood drawn. This study is currently observational, meaning it's focused on gathering information rather than testing a treatment.","The primary goals of the study will be measured at seven years.",119,"You would need to provide informed consent and have approximately 40 ml (about 2-3 tablespoons) of blood drawn by a phlebotomist.","Not stated in the trial record.",[32],"v2"]