[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609027":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":32,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ctDNA informed management arm (Watch and Wait surveillance)","EXPERIMENTAL",null,[13],"Drug: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)",{"label":15,"type":10,"description":11,"interventionNames":16},"Post TNT SOC surgery arm",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT)","Use of Signatera Genome ultra-sensitive ctDNA blood test post-total neoadjuvant therapy (TNT) for ctDNA-informed treatment management of early-stage rectal cancer.",[15,9],[24],{"name":25,"affiliation":5,"role":26},"Ankit Sarin, MD","PRINCIPAL_INVESTIGATOR",[28],{"name":25,"role":29,"phone":30,"phoneExt":11,"email":31},"CONTACT","(916) 734-3772","axsarin@health.ucdavis.edu",[33],{"facility":34,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University of California Davis Comprehensive Cancer Center","Sacramento","California","95817","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-121.4944,38.58157,{"lat":44,"lon":43},[47],{"name":25,"role":29,"phone":48,"phoneExt":11,"email":31},"916-734-3772",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[52],{"name":53,"class":54},"National Cancer Institute (NCI)","NIH","100609027","phase-2-ctdna-informed-management-of-early-stage-rectal-cancer-100609027",false,"NCT07209215","ctDNA-Informed Management of Early-Stage Rectal Cancer","ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)","ULTIMATE","Inclusion Criteria:\n\n* Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.\n* Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.\n* Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.\n* Patients ≥18 years of age at time of consent.\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Ability and stated willingness to adhere to the study visit schedule and protocol procedures\u002Frequirements.\n\nExclusion Criteria:\n\n* Prior treatment for rectal cancer, except for cohort B.\n* Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.\n* Patients on hemodialysis.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial","ALL","18 Years",{"count":66,"type":67},200,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.",[73,74,75,76],"Rectal Adenocarcinoma","Rectal Cancer","Early-stage Rectal Cancer","Locally Advanced Rectal Adenocarcinoma","NOT_YET_RECRUITING","2026-01-15",{"date":80,"type":81},"2026-01-20","ACTUAL",{"date":83,"type":67},"2026-03",{"date":85,"type":67},"2028-05",{"name":5,"class":6},1]