[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07209215":3,"trial-entities:NCT07209215":99,"trial-summary:NCT07209215":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":50,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":72,"locations":75,"central_contacts":91,"overall_officials":93,"references":97,"see_also_links":98},"NCT07209215","UCDCC322","ctDNA-Informed Management of Early-Stage Rectal Cancer","ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)","NOT_YET_RECRUITING","2028-12","2026-08","2026-08-05","2026-10","University of California, Davis","OTHER",true,"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.","Two cohorts of participants will be enrolled: Cohort A (participants appropriate for receiving TNT) and Cohort B (TNT already performed at UC Davis Health or externally). At Time A after TNT is completed and based on ctDNA assay results, the clinical decision will be made to put participants into one of two arms: the ctDNA informed management arm (Watchful Waiting \\[WW\\] surveillance) or the post TNT SOC surgery arm; participants will be monitored for ctDNA positivity for up to 5 years.",[19,20,21,22],"Rectal Adenocarcinoma","Rectal Cancer","Early-stage Rectal Cancer","Locally Advanced Rectal Adenocarcinoma",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},200,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37,38],"Post TNT SOC surgery arm","ctDNA informed management arm (Watch and Wait surveillance)",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)","Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)","Up to 2 years after TNT",{"measure":45,"description":46,"timeFrame":43},"Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm)","Percent of participants with local regrowth within 2 years of TNT",{"measure":48,"description":49,"timeFrame":43},"Disease-free survival (DFS) rate (ctDNA Informed Management Arm)","Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer.",[51],{"measure":52,"description":53,"timeFrame":43},"Frequency of local regrowth (ctDNA Informed Management Arm)","Percentage of participants with local regrowth within 2 years of TNT","ALL","18 Years",null,false,{"inclusion":59,"exclusion":66,"raw_text":71},[60,61,62,63,64,65],"Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.","Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.","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.","Patients ≥18 years of age at time of consent.","Ability to understand and willingness to sign the informed consent form (ICF).","Ability and stated willingness to adhere to the study visit schedule and protocol procedures\u002Frequirements.",[67,68,69,70],"Prior treatment for rectal cancer, except for cohort B.","Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.","Patients on hemodialysis.","Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial","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",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"University of California Davis Comprehensive Cancer Center","Sacramento","California","95817","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Office of Clinical Research","CONTACT","916-382-6970","OCRReferral@health.ucdavis.edu",{"lat":89,"lon":90},38.58157,-121.4944,[92],{"name":84,"role":85,"phone":86,"email":87},[94],{"name":95,"affiliation":13,"role":96},"Ankit Sarin, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":101},[19],[],{"nct_id":4,"found":15,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is a phase 2 study planning to enroll 200 participants. It will compare two groups: one where treatment is guided by the ctDNA blood test, and another where standard surgery is performed after TNT.","completed","ctDNA-Informed Management of Early-Stage Rectal Cancer Study","This study is looking at a new way to manage early-stage rectal cancer using a blood test called Signatera Genome ultra-sensitive ctDNA. After you've had total neoadjuvant therapy (TNT), which is chemotherapy and radiation before surgery, this blood test helps doctors decide the best next steps for your treatment. The study wants to see if this approach leads to a complete response to treatment (pathologic complete response or pathCR) and how long people live without the cancer returning (disease-free survival or DFS). You might be able to join if you have rectal adenocarcinoma, are at least 18 years old, and have tumor tissue available for testing. The study is currently unclear about its recruitment status.","Participants in the ctDNA informed management arm will be monitored for up to 2 years after TNT for pathCR and DFS. Participants will be monitored for ctDNA positivity for up to 5 years.",115,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]