[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550874":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":10,"centralContacts":10,"locations":41,"responsibleParty":100,"collaborators":10,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":10,"studyType":117,"phases":10,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Institut Investigacio Sanitaria Pere Virgili","OTHER",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Colorectal Cancer",null,"Diagnosed colorectal cancer after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy.",[13,14],"Procedure: Colonoscopy","Other: Urine and FOBT collection",{"label":16,"type":10,"description":17,"interventionNames":18},"Adenomatous high risk polyps","Diagnosed adenomatous high risk polyps after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy. With = or \\> 10 adenomas or serrated polyps and\u002For any sessile or flat lesion of = or \\>20 mm (pediculated = or \\>20 mm are not high risk).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Adenomatous medium risk polyps","Diagnosed adenomatous medium risk polyps after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy. With 5 to 9 non-advanced serrated adenomas or polyps and\u002For at least 1 advanced lesion (adenoma \\>10mm and\u002For hairy component and\u002For high-grade dysplasia or serrated polyp \\>10mm and\u002For dysplasia).",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Adenomatous low risk polyps","Diagnosed adenomatous low risk polyps after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy. With 1 to 4 non-advanced adenomas (\\\u003C10mm, without hairy component or high-grade dysplasia) or non-advanced serrated polyps (\\\u003C10mm, without dysplasia).",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Healthy","No luminal lesions are observed during the colonoscopy.",[13,14],[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"PROCEDURE","Colonoscopy","Colonoscopy performed as a regular practice during colorectal cancer screening.",[16,24,20,9,28],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Urine and FOBT collection","After patients agreement, urine and FOBT are collected before the colonoscopy and before the diet preparation of the colon.",[16,24,20,9,28],[42,77],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hospital Universitari Sant Joan de Reus","RECRUITING","Reus","Tarragona","43204","Spain","ES",{"type":51,"coordinates":52},"Point",[53,54],1.10687,41.15612,{"lat":54,"lon":53},[57,62,63,65,67,69,71,73,75],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Josep Gumà, PhD","CONTACT","+34977310300","josep.guma@salutsantjoan.cat",{"name":58,"role":59,"phone":10,"phoneExt":10,"email":10},{"name":64,"role":59,"phone":10,"phoneExt":10,"email":10},"Raquel Cumeras, PhD",{"name":66,"role":59,"phone":10,"phoneExt":10,"email":10},"Cristina Miracle, MSc",{"name":68,"role":59,"phone":10,"phoneExt":10,"email":10},"Maria Llambrich, MSc",{"name":70,"role":59,"phone":10,"phoneExt":10,"email":10},"Jaume Galceran, PhD",{"name":72,"role":59,"phone":10,"phoneExt":10,"email":10},"Teresa Sans, PhD",{"name":74,"role":59,"phone":10,"phoneExt":10,"email":10},"Francesc Martínez-Cerezo",{"name":76,"role":59,"phone":10,"phoneExt":10,"email":10},"Francesc Riu",{"facility":78,"status":44,"city":46,"state":46,"zip":79,"country":48,"countryCode":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hospital Universitari Joan XXIII","43005",{"type":51,"coordinates":81},[82,83],1.24544,41.11905,{"lat":83,"lon":82},[86,90,92,94,96,98],{"name":87,"role":59,"phone":88,"phoneExt":10,"email":89},"Joan C Quer-Boniquet, PhD","+34977295800","jquer.hj23.ics@gencat.cat",{"name":91,"role":59,"phone":10,"phoneExt":10,"email":10},"Joan C Quer-Boniquet, MD",{"name":93,"role":59,"phone":10,"phoneExt":10,"email":10},"Belén Ballesté-Peris, MD",{"name":95,"role":59,"phone":10,"phoneExt":10,"email":10},"Lidia Cabrinety-Fernández, MD",{"name":97,"role":59,"phone":10,"phoneExt":10,"email":10},"Maria L Díaz-Fernández, MD",{"name":99,"role":59,"phone":10,"phoneExt":10,"email":10},"Miriam Gené-Hijós, MD",{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Raquel Cumeras","Principal Investigator","100550874","early-diagnosis-of-colorectal-cancer-based-on-a-non-invasive-metabolomics-profile-100550874",false,"NCT06452745","Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile","EarlyCRC","Inclusion Criteria:\n\n* Patients with a positive FOBT test result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy.\n\nExclusion Criteria:\n\n* Patients diagnosed with another primary neoplasm in the last 5 years, with the exception of carcinoma in situ of the cervix or non-melanoma skin cancer.\n* Patients with severe kidney disease stage IV (creatinine clearance \\\u003C 30 ml\u002Fmin).\n* Patients with severe active liver disease (hepatitis, cirrhosis).\n* Refusal to sign informed consent.","ALL","50 Years","70 Years",{"count":115,"type":116},2000,"ESTIMATED","OBSERVATIONAL","Colorectal cancer is the most frequent tumor in our environment if both sexes are considered together. Every year almost 800 cases are diagnosed in the districts of Tarragona. A little more than half of colorectal cancers are cured with surgery, with or without the addition of complementary treatments with chemotherapy and\u002For radiation therapy. Those who are not cured is because at the time of diagnosis the disease has already spread or they spread after having been treated surgically with curative intent.\n\nThe purpose of the EarlyCRC project is to determine whether metabolites (substances of low molecular weight) can be found in the urine and stool of patients with colorectal cancer or polyps that can be easily and cheaply differentiated (urine or stool analysis) between the patients affected by colorectal cancer or polyps, from healthy individuals. For the identification of these possible metabolites, the urine analysis will be performed using the usual techniques in metabolomics, which studies the existing metabolites in biological processes.",[9,120,121,28],"Colorectal Adenoma","Colorectal Polyp",[123,124,125,126,127],"screening","urine","fobt","biomarkers","metabolomics","2024-09-30",{"date":130,"type":131},"2024-10-02","ACTUAL",{"date":133,"type":131},"2019-07-20",{"date":135,"type":116},"2040-06-30",{"name":5,"class":6},2]