{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2010"],"data_sharing_plan":["IPD Sharing (as of March 2023): Yes\nDescription: Data will be shared in an upcoming publication."],"condition":["In this study our primary objective is to induce or enhance an immune response to tumor antigens in Lynch syndrome mutation carriers (with and without colorectal adenomas or carcinomas) and patients with sporadic colorectal cancer (CRC) showing microsatellite instability (MSI-high), the hallmark of MMR dysfunction, and test the hypothesis that DC vaccination might be effective as prophylactic treatment in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) or Lynch syndrome mutation carriers.","Colorectal Cancer","Colorectal Neoplasms","Colorectal Neoplasms, Hereditary Nonpolyposis"],"disease":["In This Study Our Primary Objective Is To Induce Or Enhance An Immune Response To Tumor Antigens In Lynch Syndrome Mutation Carriers (with And Without Colorectal Adenomas Or Carcinomas) And Patients With Sporadic Colorectal Cancer (crc) Showing Microsatellite Instability (msi-high), The Hallmark Of Mmr Dysfunction, And Test The Hypothesis That Dc Vaccination Might Be Effective As Prophylactic Treatment In Hereditary Non-polyposis Colorectal Cancer (hnpcc) Or Lynch Syndrome Mutation Carriers.","Colorectal Cancer","Colorectal Neoplasms","Colorectal Neoplasms, Hereditary Nonpolyposis"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2147264"],"location":["Netherlands"],"study_start_month":["10"],"keyword":["Peptide-loaded Dendritic cell product","CRC","Immunotherapy","Vaccines","Dendritic cell vaccination","MSI-high colorectal cancer (CRC)","Germline MMR-gene mutation without disease criteria of CRC"],"repository":["ECRIN MDR"],"study_status":["Active, not recruiting"],"additional_accession":[]},"is_claimable":false,"name":"Dendritic Cell Vaccination in Patients With Lynch Syndrome or Colorectal Cancer With MSI","description":"Objectives:\nIn this Radboud University Nijmegen Medical Centre (RUNMC) initiated study our first objective is to investigate toxicity (safety and feasibility) of vaccination with frameshift-derived neoantigen-loaded DC of CRC patients with an MSI-positive CRC and persons who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.\nThe secondary objectives of the study are:\n* to demonstrate that peptide-loaded DC can induce or enhance an immune response to tumor-associated antigen CEA and specific frameshift-derived neoantigens in the study population.\n* to study the pathological and clinical responses, e.g. disease-free survival, determined according to the standard protocol.\nStudy design:\nThis study is a phase I/II open-label study.\nStudy population:\nTwo groups of adults will be vaccinated:\nGroup I) CRC patients, who are known to carry a germline MMR-gene mutation and patients with an MSI-positive CRC and yet unknown or negative MMR-gene mutation status.\nGroup II) persons who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet. All participants need to be HLA-A2.1 positive.","dates":{"creation":"2010-10-15"},"accession":"2147264","cross_references":{"ClinicalTrials___gov":["NCT01885702"],"EU Clinical Trials Register":["2008-005584-33"]}}