[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651051":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":27,"locations":10,"responsibleParty":33,"collaborators":10,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":10,"enrollmentInfo":45,"targetDuration":10,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":10},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Retrospective cohort",null,"The retrospective cohort will include 160 patients with metastatic colorectal cancer (mCRC) who have previously received first-line systemic therapy (chemotherapy with or without targeted biological agents). Biological samples and corresponding clinical data, collected as part of routine clinical practice between 2017 and 2025, will be retrospectively analyzed.",{"label":13,"type":10,"description":14,"interventionNames":15},"Prospective cohort","The prospective cohort will include 130 treatment-naïve patients with metastatic colorectal cancer (mCRC) who will be prospectively enrolled at the start of first-line systemic therapy for longitudinal collection of biological samples and clinical data.",[16],"Other: Blood sample",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Blood sample","Collection, in conjunction with blood sampling performed as part of routine clinical practice, of a 9 mL blood sample in an EDTA tube at the following time points: before treatment initiation, at the first radiological reassessment, and at disease progression. This sample collection is part of the standard clinical management of patients with metastatic colorectal cancer (mCRC).",[13],[23],{"name":24,"affiliation":25,"role":26},"Donatella Lucchetti, PhD","Catholic University of the Sacred Heart","STUDY_DIRECTOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Maria Alessandra Calegari, MD","CONTACT","0630156318","mariaalessandra.calegari@gmail.com",{"type":34,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651051","circulating-tumor-extracellular-vesicles-for-non-invasive-monitoring-of-metastatic-colorectal-cancer-100651051",false,"NCT07754513","Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer","Circulating Tumor Extracellular Vesicles As Novel Non-invasive Biomarkers to Monitor Metastatic Colorectal Cancer Transcriptomic and Proteomic Evolution","EVA26","Retrospective Cohort Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed diagnosis of colorectal adenocarcinoma;\n* Radiological evidence of metastatic or locally advanced unresectable disease;\n* First-line treatment for metastatic disease already completed or ongoing according to standard clinical practice;\n* Availability of stored biological samples collected at least at one of the protocol-defined time points (baseline, post-treatment, disease progression);\n* Informed consent acquisition will be performed in accordance with Article 110-bis of the Italian Privacy Code.\n\nRetrospective Cohort Exclusion Criteria:\n\n* Absence of suitable biological samples or samples unsuitable for molecular analyses;\n* Incomplete clinical data preventing the performance of the planned analyses;\n* Insufficient quality of stored biological samples for the assessment of EV-RNA and EV-PROT analyses.\n\nProspective Cohort Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed diagnosis of colorectal adenocarcinoma;\n* Radiological evidence of unresectable metastatic disease;\n* Patients not previously treated for metastatic disease (prior completed adjuvant\u002Fneoadjuvant therapy is allowed if completed ≥ 6 months before study enrollment);\n* Indication for first-line treatment with chemotherapy ± biological therapy according to standard clinical practice;\n* Ability to understand the study procedures and provide written informed consent.\n\nProspective Cohort Exclusion Criteria:\n\n* Previous systemic treatment for metastatic disease (except prior adjuvant\u002Fneoadjuvant therapy as specified above);\n* Ongoing pregnancy or breastfeeding;\n* Legal incapacity or limitation in the ability to provide informed consent.","ALL","18 Years",{"count":46,"type":47},290,"ESTIMATED","OBSERVATIONAL","Metastatic colorectal cancer (mCRC) remains a major clinical challenge due to heterogeneous treatment responses and the development of therapeutic resistance. Current tissue-based molecular profiling is limited by invasiveness and the inability to enable longitudinal monitoring. Extracellular vesicles (EVs) represent a promising source of non-invasive biomarkers, carrying stable RNA and proteins reflective of tumor biology. This study aims to identify and validate EV-derived transcriptomic and proteomic biomarkers to monitor disease evolution, predict treatment response, and support personalized management of patients with mCRC.",[51],"Metastatic Colorectal Cancer",[53,54],"Circulating extracellular vesicles (EVs)","Biomarker discovery","NOT_YET_RECRUITING","2026-08-04",{"date":58,"type":59},"2026-08-10","ACTUAL",{"date":61,"type":47},"2026-09-01",{"date":63,"type":47},"2029-09-01",{"name":5,"class":6}]