[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oncoliq US Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100618429","validation-of-the-oncoliq-test-for-the-early-detection-of-breast-cancer-100618429",false,"NCT07331506","Validation of the Oncoliq Test for the Early Detection of Breast Cancer.","Inclusion Criteria:\n\nGroup 1 - Breast Cancer:\n\nAge between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent\n\nGroup 2 - No Cancer (Control):\n\nAge between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent\n\nExclusion Criteria:\n\nRefusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer",true,"FEMALE","40 Years","70 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.\n\nMicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.\n\nThe research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.\n\nThe objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.",[25,26,27,28,29,30,31,32],"Breast Cancer Detection","Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Cancer Female","Breast Cancer - Ductal Carcinoma in Situ (DCIS)","Breast Cancer - Infiltrating Ductal Carcinoma","Breast Cancer With Low to Intermediate HER2 Expression","Breast Cancer (Early Breast Cancer)","Breast Cancer - Female",[34,35,36,37],"Breast cancer","Detection","Liquid biopsy","miRNAs","RECRUITING","2026-01-13",{"date":41,"type":42},"2026-01-15","ACTUAL",{"date":44,"type":42},"2025-10-17",{"date":46,"type":21},"2026-02-28",{"name":48,"class":49},"Oncoliq US Inc","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":15,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":50},"100549890","oncoliq-early-breast-cancer-detection-based-on-liquid-biopsies-and-micrornas-100549890","NCT06439940","Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs","Pilot Test for an Early Diagnosis Kit for Breast Cancer Based on Liquid Biopsies","Inclusion Criteria:\n\n* Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up\n\nExclusion Criteria:\n\n* Personal history of cancer","35 Years",{"count":60,"type":21},364,"Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test aims to improve the accuracy of cancer detection, thereby reducing patient mortality and healthcare costs.\n\nTo develop this test, the discovery and validation phases have been completed. In addition, Machine learning and AI were used to determine the algorithm for breast cancer detection.\n\nThe overall objective of this protocol is to implement a pilot test to enroll 1,000 women without a previous cancer diagnosis who are attending their annual medical check-up.\n\nTo achieve this, we will develop the following specific objectives:\n\nEnroll women over age 35 who attend the gynecological annual check-up. Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR.\n\nPerform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems (USA) on mammogram images.\n\nCompare the results obtained from the clinical check-up (BiRad from mammogram), IMAGO Systems and RT-qPCR (Oncoliq breast test). Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test.\n\nParticipants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey. Subsequently, a small blood sample of 3-5 mL will be drawn via venipuncture.",[27,63,64],"Breast Cancer","Breast Carcinoma",[66,67,68,69,37,70,71,72,73,74,75,76,77],"early diagnosis","early detection","cancer","breast cancer","liquid biopsies","pilot study","pilot test","liquid biopsy","Oncoliq","machine learning","AI","RT-qPCR","2024-06-05",{"date":80,"type":42},"2024-06-07",{"date":82,"type":42},"2021-07-14",{"date":84,"type":21},"2025-03-31",{"name":48,"class":49},""]