[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06878131":3,"trial-entities:NCT06878131":70,"trial-summary:NCT06878131":79},{"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":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":30,"secondary_outcomes":34,"sex":35,"minimum_age":36,"maximum_age":21,"healthy_volunteers":21,"eligibility_criteria":37,"std_ages":41,"locations":44,"central_contacts":60,"overall_officials":62,"references":65,"see_also_links":66},"NCT06878131","2024-1886","Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease","RECRUITING","2028-12-22","2026-05","2026-05-22","2025-04-18","M.D. Anderson Cancer Center","OTHER",false,"The goal of this clinical research study is to learn about the effects of biomarkertargeted therapy on ctDNA in patrticipants with CRC and MRD.\n\nThis is an observational study. Participants will be monitored while receiving biomarker-directed therapy that is determined by your treating oncologist (cancer doctor) per standard of care, independent of this study.","Primary Objective\n\n• To estimate the rate of ctDNA clearance at 6 months following initiation of biomarker-directed targeted therapy in colorectal cancer (CRC) participants with minimal residual disease (MRD).\n\nSecondary Objectives\n\n* To evaluate dynamics of ctDNA mutant allele fractions following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.\n* To estimate the rate of disease recurrence at 1 year following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.",[18],"Colorectal Cancer",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},40,"ESTIMATED",[27],{"type":28,"name":18,"description":29},"BEHAVIORAL","Participants that take part in this research, will be responsible for following study directions and allowing blood samples to be collected every 3 months for correlative studies.",[31],{"measure":32,"timeFrame":33},"Safety and Adverse events (AEs)","Through study completion; an average of 1 year.",[],"ALL","18 Years",{"inclusion":38,"exclusion":39,"raw_text":40},[],[],"Inclusion Criteria\n\n1. Male or female subjects aged \\> 18 years.\n2. Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.\n3. Stage II-IV disease per current AJCC staging criteria with no definitive radiographic evidence of disease following locoregional treatment. Small indeterminate lesions measuring \\\u003C 10 mm may be permitted at the discretion of the principal investigator.\n4. Presence of one of the following targetable biomarkers on tumor or blood molecular testing: BRAF V600E mutation (Cohort A), KRAS G12C mutation (Cohort B), MSI-H status (Cohort C), and HER2 amplification (Cohort D).\n5. Positive ctDNA blood test obtained \\> 21 days after surgery or last administration of adjuvant therapy.\n6. Prescribed one of the following standard-of-care targeted therapy regimens: BRAF V600E Inhibitor + anti-EGFR antibody for BRAF V600E-mutated tumors, KRAS G12C Inhibitor + anti-EGFR antibody for KRAS G12C-mutated tumors, anti-PD-1 antibody +\u002F- anti-CTLA-4 antibody for MMRd\u002FMSI-H tumors, or anti-HER2 therapies for HER2 amplified tumors.\n\nExclusion Criteria\n\n1. Prior exposure to the following classes of biomarker-directed therapies: BRAF V600E inhibitors, anti-EGFR antibodies, KRAS G12C inhibitors, anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 therapies\n2. Presence of a concurrent malignancy requiring active treatment\n3. Inability to provide informed consent\n4. Children will not be enrolled in this study\n5. Pregnant women will not be enrolled in this study\n6. Cognitively Impaired subjects will not be enrolled in this study",[42,43],"ADULT","OLDER_ADULT",[45],{"facility":46,"status":7,"city":47,"state":48,"zip":49,"country":50,"contacts":51,"geoPoint":57},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[52],{"name":53,"role":54,"phone":55,"email":56},"Saurav Haldar, MD","CONTACT","713-792-2828","GIClinicalTrials@mdanderson.org",{"lat":58,"lon":59},29.76328,-95.36327,[61],{"name":53,"role":54,"phone":55,"email":56},[63],{"name":53,"affiliation":12,"role":64},"PRINCIPAL_INVESTIGATOR",[],[67],{"label":68,"url":69},"Related Info","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":71,"biomarkers":73},[72],"Colorectal Carcinoma",[74,75,76,77,78],"BRAF Gene","Circulating Tumor-Derived DNA Negative","ERBB2 Gene","GTPase KRas","MSI1 Gene",{"nct_id":4,"found":80,"summary":81,"prompt_version":91},true,{"design":82,"status":83,"heading":84,"summary":85,"follow_up":86,"word_count":87,"commitments":88,"compensation":89,"drugs_mentioned":90},"This is an observational study with 40 planned participants. It is not a randomized trial, meaning treatments are not assigned by the study.","completed","Observational Study for Colorectal Cancer with Minimal Residual Disease","This study is for people with colorectal cancer (CRC) who have minimal residual disease (MRD), meaning a small amount of cancer cells remain after initial treatment. The goal is to see how well biomarker-directed therapies (treatments chosen based on specific features of your cancer, like BRAF or KRAS mutations) help clear these remaining cancer cells, as measured by circulating tumor DNA (ctDNA) in your blood. You would receive treatment decided by your doctor as part of your usual care. Researchers will monitor your progress and collect blood samples every three months to understand how these treatments affect your ctDNA and the chance of your cancer returning. To join, you must be over 18, have a confirmed diagnosis of colorectal adenocarcinoma, and have no clear signs of cancer on scans after initial treatment.","Your safety and side effects will be monitored through study completion, which is an average of 1 year.",132,"You will follow your doctor's treatment plan and provide blood samples every 3 months for correlative studies.","Not stated in the trial record.",[18],"v2"]